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PANADOL PM

Medically reviewed by Drugs.com. Last updated on Sep 23, 2021.

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0608

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

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.
with any other product containing diphenhydramine, even one used on skin
in children under 12 years of age
if you are allergic to acetaminophen or any of the inactive ingredients in this product

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 25°C (77°F)

Inactive ingredients

carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-800-455-7139

Principal Display Panel

NDC 0135-0608-01

PANADOL

EXTRA STRENGTH

PM

ACETAMNOPHEN

Pain Reliever

DIPHENHYDRAMINE HCl

Nighttime Sleep-Aid

24 CAPLETS

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

READ AND KEEP CARTON FOR COMPLETE INFORMATION

Trademarks are owned by or licensed to the GSK group of companies.

Distributed by:

GSK Consumer Healthcare, Warren, NJ 07059

©2016 GSK group of companies or its licensor.

101639XE

PANADOL  PM
acetaminophen and diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0608
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
CARNAUBA WAX 
CROSPOVIDONE (15 MPA.S AT 5%) 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYSORBATE 80 
POVIDONE, UNSPECIFIED 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVAL (Caplet) Size17mm
FlavorImprint CodePM
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0608-011 BOTTLE in 1 CARTON
124 TABLET, FILM COATED in 1 BOTTLE
2NDC:0135-0608-021 BOTTLE in 1 CARTON
250 TABLET, FILM COATED in 1 BOTTLE
3NDC:0135-0608-0350 PACKET in 1 CARTON
3NDC:0135-0608-042 TABLET, FILM COATED in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/01/2016
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.