PANADOL PM

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 0135-0150

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.

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purposes

Pain reliever

Nighttime sleep-aid

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
3 or more alcoholic drinks every day while using this product

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.
with any other product containing diphenhydramine, even one used on skin
in children under 12 years of age
with other antihistamines

Ask a doctor before use if you have
liver disease
glaucoma
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.
pain gets worse or lasts more than 10 days
redness or swelling is present
any new symptoms appear

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

Overdose warning:

Taking more than the recommended dose can cause serious health problems. 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
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

Other Information
store below 30°C (86°F)

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.

Questions or comments?

1-800-981-3511 (English/Spanish) weekdays

Tamper Evident Feature: Do not use if printed bottle seal (under cap) is missing or broken.

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108 U.S.A.

Read and keep carton for complete information

Principal Display Panel

NDC 0135-0150-02

PANADOL

EXTRA STRENGTH

PM

ACETAMINOPHEN

Pain Reliever

DIPHENHYDRAMINE HCl

Nighttime Sleep-Aid

50 Caplets

©2011 GlaxoSmithKline

101689XA

PANADOL  PM
acetaminophen and diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0150
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
HYPROMELLOSES 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 80 
POTASSIUM SORBATE 
POVIDONES 
STARCH, CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVAL (Caplet) Size17mm
FlavorImprint CodePanadol;PM
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0150-0350 PACKET in 1 CARTON
1NDC:0135-0150-042 TABLET, FILM COATED in 1 PACKET
2NDC:0135-0150-0124 TABLET, FILM COATED in 1 BOTTLE
3NDC:0135-0150-0250 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/23/2011
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 09/2013
 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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