PANADOL PM- acetaminophen and diphenhydramine hcl 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
- •
- 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
- •
- more than 4,000 mg of acetaminophen in 24 hours
- •
- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert:
acetaminophen may cause severe skin reactions. Symptoms may include:
- •
- skin reddening
- •
- blisters
- •
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- •
- 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
- •
- in children under 12 years of age
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- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
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- liver disease
- •
- glaucoma
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- a breathing problem such as emphysema or chronic bronchitis
- •
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking
- •
- the blood thinning drug warfarin
- •
- sedatives or tranquilizers
When using this product
- •
- drowsiness will occur
- •
- avoid alcoholic drinks
- •
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- •
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
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- pain gets worse or lasts more than 10 days
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- redness or swelling is present
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- any new symptoms appear
These could be signs of a serious condition.
Directions
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- do not take more than directed (see overdose warning)
- •
- adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
- •
- do not give to children under 12 years of age
Inactive ingredients
FD&C blue #1, FD&C blue #2, hypromellose, polyethylene glycol, polysorbate 80, potassium sorbate, povidone, pregelatinized starch, starch, stearic acid, talc, titanium dioxide. Printed with edible ink.
Principal Display Panel
NDC 0135-0150-02
PANADOL®
EXTRA STRENGTH
PM
ACETAMINOPHEN
Pain Reliever
DIPHENHYDRAMINE HCl
Nighttime Sleep-Aid
SEE NEW WARNINGS INFORMATION
50 CAPLETS
Tamper Evident Feature: Do not use if printed bottle seal (under cap) is missing or broken.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
PANADOL and the Beacon design are registered trademarks of the GSK group of companies.
Keep Carton
GlaxoSmithKline Consumer Healthcare, L.P.
Moon Township, PA 15108
Made in Ireland
©2014 GSK group of companies.
All Rights Reserved.
101689XB
| PANADOL
PM
acetaminophen and diphenhydramine hcl tablet, film coated |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |