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Children's Tylenol Suspension Liquid and Meltaways, Junior Tylenol Meltaways, Concentrated Tylenol Infants Drops (McNeil Consumer)
TYLENOL®
acetaminophen MeltawaysProduct information for all dosages of Children's TYLENOL have been combined under this heading
DESCRIPTION
Concentrated TYLENOL® Infants' Drops are stable, alcohol-free, grape-flavored and purple in color or cherry-flavored and red in color. Each 1.6 mL contains 160 mg acetaminophen. Concentrated TYLENOL® Infants' Drops features the SAFE-TY-LOCK™ Bottle. The SAFE-TY-LOCK™ Bottle has a unique safety barrier inside the bottle which helps make administration easier. The integrated dropper promotes proper administration. The innovative design eliminates excess product on dropper. The star-shaped barrier inside the bottle minimizes spills and discourages pouring into a spoon. Children's TYLENOL® Suspension Liquid is stable, alcohol-free, cherry blast-flavored and red in color, bubblegum yum-flavored and pink in color, grape splash-flavored and purple in color, or very berry strawberry-flavored and red in color. Each 5 mL (one teaspoonful) contains 160 mg acetaminophen. Each Children's TYLENOL® Meltaways contains 80 mg acetaminophen in a grape punch, bubblegum burst or wacky watermelon flavor. Each Jr. TYLENOL® Meltaways contains 160 mg acetaminophen in grape punch or bubblegum burst flavor.
ACTIONS
Acetaminophen is a clinically proven analgesic/antipyretic. Acetaminophen produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulating center. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness and it is unlikely to produce many of the side effects associated with aspirin and aspirin-containing products.
USES
Concentrated TYLENOL® Infants' Drops: temporarily:
- reduces fever
- relieves minor aches and pains due to: · the common cold · flu · headache · sore throat · toothache
Children's TYLENOL® Suspension Liquid and Children's TYLENOL® Meltaways: temporarily relieves minor aches and pains due to: · the common cold · flu · headaches · sore throat · toothache
· temporarily reduces fever
Jr. TYLENOL® Meltaways: temporarily relieves minor aches and pains due to: · the common cold · flu · headache
· temporarily reduces fever
DIRECTIONS
See Table 1: Children's Tylenol Dosing Chart on pg. __
WARNINGS
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly (excluding Jr. TYLENOL® Meltaways ).
Do not use
- with any other product containing acetaminophen
When using this product
- do not exceed recommended dose (see overdose warning)
Stop use and ask a doctor if
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts for more than 5 days
- fever gets worse or lasts for more than 3 days
Keep out of the reach of children.
Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Other Information:
Concentrated TYLENOL® Infants' Drops:
- do not use if plastic carton wrap or bottle wrap imprinted "Safety Seal®" is broken or missing.
- store at room temperature
- see bottom panel of carton for expiration date and lot number
Children's TYLENOL® Suspension Liquid:
- do not use if bottle wrap, or foil inner seal imprinted "Safety Seal®" is broken or missing
- store between 20-25°C (68-77°F)
- see bottom panel for lot number and expiration date
Children's TYLENOL® Meltaways:
- do not use if carton is opened or if neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing.
- store between 20-25°C (68-77°F). Avoid high humidity. (Grape Rush: Protect from light).
- see end panel for lot number and expiration date
Jr. TYLENOL® Meltaways:
- do not use if carton is opened or if blister unit is broken
- store between 20-25°C (68-77°F). Avoid high humidity. (Grape Punch: Protect from light).
- see end panel for lot number and expiration date
PROFESSIONAL INFORMATION :
OVERDOSAGE INFORMATIONfor all Infants', Children's & Jr. Tylenol® Products
Acetaminophen: Acetaminophen in massive overdosage may cause hepatic toxicity in some patients. In adults and adolescents (>/= 12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 grams over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion. In adults and adolescents, any individual presenting with an unknown amount of acetaminophen ingested or with a questionable or unreliable history about the time of ingestion should have a plasma acetaminophen level drawn and be treated with N -acetylcysteine. For full prescribing information, refer to the N -acetylcysteine package insert. Do not await results of assays for plasma acetaminophen levels before initiating treatment with N -acetylcysteine. The following additional procedures are recommended: Promptly initiate gastric decontamination of the stomach. A plasma acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N -acetylcysteine treatment should be continued for a full course of therapy. Liver function studies should be obtained initially and repeated at 24-hour intervals. Serious toxicity or fatalities have been extremely infrequent following an acute acetaminophen overdose in young children, possibly because of differences in the way they metabolize acetaminophen. In children, the maximum potential amount ingested can be more easily estimated. If more than 150 mg/kg or an unknown amount was ingested, obtain a plasma acetaminophen level as soon as possible, but no sooner than 4 hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N- acetylcysteine treatment should be initiated and continued for a full course of therapy. If an assay cannot be obtained and the estimated acetaminophen ingestion exceeds 150 mg/kg, dosing with N -acetylcysteine should be initiated and continued for a full course of therapy. For additional emergency information, call your regional poison center or call the Rocky Mountain Poison Center toll-free, (1-800-525-6115).
Our pediatric Tylenol® combination products contain active ingredients in addition to acetaminophen. The following is basic overdose information regarding those ingredients.
Chlorpheniramine: Chlorpheniramine toxicity should be treated as you would an anthihistamine/anticholinergic overdose and is likely to be present within a few hours after acute ingestion.
Dextromethorphan: Acute dextromethorphan overdose usually does not result in serious signs and symptoms unless massive amounts have been ingested. Signs and symptoms of a substantial overdose may include nausea and vomiting, visual disturbances, CNS disturbances and urinary retention.
Diphenhydramine: Diphenhydramine toxicity should be treated as you would an antihistamine/anticholinergic overdose and is likely to be present within a few hours after acute ingestion.
Pseudoephedrine: Symptoms from pseudoephedrine overdose consist most often of mild anxiety, tachycardia and/or mild hypertension. Symptoms usually appear within 4 to 8 hours of ingestion and are transient, usually requiring no treatment.
For additional emergency information, please contact your local poison control center.
Inactive Ingredients:
Concentrated TYLENOL® Infants' Drops: Cherry-Flavored: cellulose, citric acid, corn syrup, FD&C Red #40, flavors, glycerin, purified water, sodium benzoate, sorbitol, xanthan gum. Grape-Flavored: cellulose, citric acid, corn syrup, D&C red #33, FD&C Blue #1, flavors, glycerin, purified water, sodium benzoate, sorbitol, xanthan gum.
Children's TYLENOL® Suspension Liquid: butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum. In addition to the above ingredients cherry blast-flavored suspension contains FD&C red #40, bubblegum-yum-flavored suspension contains D&C red #33 and FD&C red #40, grape splash-flavored suspension contains D&C red #33 and FD&C blue #1 and very berry strawberry-flavored suspension contains FD&C red #40.
Children's TYLENOL® Meltaways: Wacky Watermelon-Flavored: cellulose acetate, citric acid, crospovidone, D&C red #30, dextrose, flavors, magnesium stearate, povidone, sucralose. Grape-Punch-Flavored: cellulose acetate, citric acid, crospovidone, dextrose, D&C red #7, D&C red #30, FD&C blue #1, flavors, magnesium stearate, povidone, sucralose. Bubblegum Burst-Flavored: cellulose acetate, citric acid, crospovidone, D&C red #7, dextrose, flavors, magnesium stearate, povidone, sucralose.
Jr. TYLENOL® Meltaways Bubblegum Burst Flavored: cellulose acetate, citric acid, crospovidone, D&C red #7, dextrose, flavors, magnesium stearate, povidone, sucralose. Grape Punch Flavored: cellulose acetate, citric acid, crospovidone, D&C red #7, D&C red #30, dextrose, FD&C blue #1, flavors, magnesium stearate, povidone, sucralose.
HOW SUPPLIED
Concentrated TYLENOL® Infants' Drops: (purple-colored grape): bottles of ½ oz (15 mL) and 1 oz (30 mL); (red-colored cherry): bottles of ½ oz and 1 oz, each with calibrated plastic dropper.
Children's TYLENOL® Suspension Liquid: (red-colored cherry blast): bottles of 2 and 4 fl oz. (pink-colored bubblegum yum, purple-colored grape splash and red-colored very berry strawberry): bottles of 4 fl. oz.
Children's TYLENOL® Meltaways: (red-colored wacky watermelon, purple-colored grape punch, pink-colored bubblegum burst, scored, imprinted "TY80"). Bottles of 30 and also blister packaged 48's and 64's.
Jr. TYLENOL® Meltaways: (purple-colored grape punch or pink-colored bubblegum burst, imprinted "TY 160"). Blister packaged 24's and 48's. All packages listed above are safety sealed and use child-resistant safety caps or blisters.
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