EXCEDRIN PM- acetaminophen, diphenhydramine citrate tablet, film coated
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Drug Facts
Uses
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 2 caplets in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Do Not Use
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- if you are allergic to acetaminophen
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- with any other product containing diphenhydramine, even one used on skin
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- in children under 12 years of age
Ask a doctor before use if you have
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- liver disease
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- glaucoma
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- a breathing problem such as emphysema or chronic bronchitis
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- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
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- taking the blood thinning drug warfarin
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- taking sedatives or tranquilizers
When using this product
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- avoid alcoholic drinks
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- drowsiness may occur
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- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
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- any new symptoms occur
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- sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
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- pain gets worse or lasts for more than 10 days
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- painful area is red or swollen
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- fever gets worse or lasts for more than 3 days
Overdose
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Directions
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- do not use more than directed
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- do not use in children under 12 years of age
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- adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
Other information
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- store at controlled room temperature 20°-25°C (68°-77°F)
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- read all product information before using. Keep this box for important information.
Inactive ingredients
benzoic acid, carnauba wax, croscarmellose sodium, D&C yellow #10 lake, FD&C blue #1 lake, hypromellose, light mineral oil, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone, pregelatinized starch, propylene glycol, simethicone emulsion, sodium citrate, sorbitan monolaurate, stearic acid, titanium dioxide
Questions or comments?
1-800-468-7746
Distr. By: Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622 ©2008
Visit us at www.excedrin.com
| EXCEDRIN
PM
acetaminophen, diphenhydramine citrate tablet, film coated |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |