Tagamet HB 200 Tablets (Glaxosmithkline)

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Tagamet HB® 200 relieves and prevents heartburn, acid indigestion and sour stomach when used as directed. It contains the same ingredient found in prescription strength Tagamet. Tagamet HB 200 reduces the production of stomach acid.

Active Ingredient:    Cimetidine, 200 mg.

Inactive Ingredients:    Cellulose, cornstarch, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide.

Uses:

• For relief of heartburn associated with acid indigestion and sour stomach.
• For prevention of heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.

Directions:

• For relief of symptoms, swallow 1 tablet with a glass of water.
• For prevention of symptoms, swallow 1 tablet with a glass of water right before or anytime up to 30 minutes before eating food or drinking beverages that cause heartburn.
• Tagamet HB 200 can be used up to twice daily (up to 2 tablets in 24 hours).
• This product should not be given to children under 12 years old unless directed by a doctor.

Warnings:

Allergy Warning:    Do not use if you are allergic to Tagamet HB 200 (cimetidine) or other acid reducers.

Ask a Doctor Before Use If You are Taking:

• theophylline (oral asthma medicine)
• warfarin (blood thinning medicine)
• phenytoin (seizure medicine)

If you are not sure whether your medication contains one of these drugs or have any other questions about medicines you are taking, call our consumer affairs specialist at 1-800-482-4394.

• Do not take the maximum daily dosage for more than 2 weeks continuously except under the advice and supervision of a doctor.
• If you have trouble swallowing, or persistent abdominal pain, see your doctor promptly. You may have a serious condition that may need a different treatment.
• As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
• Keep this and all medications out of the reach of children.
• In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

READ THE LABEL

Read the directions and warnings before taking this medication.

Store at 15°-30°C (59°-86°F).

Comments or questions? Call Toll-Free 1-800-482-4394 weekdays.

PHARMACOKINETIC INTERACTIONS

Cimetidine at prescription doses is known to inhibit various P450 metabolizing isoenzymes, which could affect metabolism of other drugs and increase their blood concentration. Investigation of pharmacokinetic interactions at the recommended OTC doses of cimetidine have thus far shown only small effects.

A pharmacokinetic study conducted in 26 normal male subjects (mean age, 38 years) at steady state using the maximum recommended OTC dose level (200 mg twice a day), showed that Tagamet HB 200, on average, increased the 24 hour AUC of theophylline by 14% and increased peak theophylline levels by 15%. This interaction should be borne in mind in advising patients on the use of Tagamet HB 200. At the prescription doses of cimetidine, clinically significant pharmacokinetic interactions between cimetidine and warfarin, phenytoin, and theophylline have been reported. At prescription doses, pharmacokinetic interactions have been reported for a number of other drugs as well, such as with dihydropyridine calcium channel blockers or some short acting benzodiazepines. At the maximum recommended OTC dose level (200 mg twice a day), a pharmacokinetic study conducted in 21 normal male subjects (mean age, 38 years) showed that Tagamet HB 200, on average, increased the total AUC of triazolam by 26-28% and increased peak triazolam levels by 11-23%. Tagamet HB 200 did not alter the apparent terminal elimination half-life of triazolam.

How Supplied:    Tagamet HB 200 (Cimetidine Tablets 200 mg) is available in boxes of blister packs in 6, 30, 50, & 70 tablet sizes.

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