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Excedrin PM Triple Action Caplets

Medically reviewed on Mar 29, 2017

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 250mg, ASPIRIN 250mg, DIPHENHYDRAMINE CITRATE 38mg
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0067-2056

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 250 mg

Aspirin 250 mg (NSAID*)

Diphenhydramine citrate 38 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain Reliever

Pain Reliever

Nighttime sleep-aid

Uses
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

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.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

hives
facial swelling
asthma (wheezing)
shock

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 2 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Do not use
if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
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

Ask a doctor before use if
you have liver disease
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic
you have asthma
you have glaucoma
you have a breathing problem such as emphysema or chronic bronchitis
you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking

a prescription drug for:
o
diabetes
o
gout
o
arthritis
any other drug, or are under a doctor’s care for any serious condition
any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
sedatives or tranquilizers

When using this product
drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if
an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:
o
feel faint
o
vomit blood
o
have bloody or black stools
o
have stomach pain that does not get better
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
pain gets worse or last for more than 10 days
painful area is red or swollen
ringing in the ears or a loss of hearing occurs
any new symptoms occur

These could be signs of a serious condition

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

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 use more than directed
do not use in children under 12 years of age
adults and children 12 years of age and over: take 2 caplets at bedtime, with a full glass of water
do not take more than 2 caplets in 24 hours, unless directed by a doctor

Other information
store at 20°-25°C (68°-77°F).
close cap tightly after use.
read all product information before using. Keep this box for important information.

Inactive ingredients

benzoic acid, calcium carbonate, FD&C blue#1 aluminum lake, hydroxypropyl cellulose low substituted, hypromellose, magnesium stearate, maltodextrin, medium-chain triglycerides, polydextrose, polysorbate 80, povidone, pregelatinized corn starch, silicified microcrystalline cellulose, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate

Questions or comments?

1-800-452-0051

Principal Display Panel

NDC 0067-2056-24

EXCEDRIN®

PM HEADACHE

Acetaminophen, Aspirin (NSAID) and Diphenhydramine Citrate

Pain Reliever/Nighttime Sleep-Aid

Triple Action Formula

Caffeine-Free

Non-Habit Forming

24 CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

©2015 GSK or its licensor.

Visit us at www.excedrin.com

46172695

EXCEDRIN PM TRIPLE ACTION CAPLETS 
acetaminophen, aspirin (nsaid) and diphenhydramine citrate tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2056
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE) DIPHENHYDRAMINE CITRATE38 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
CALCIUM CARBONATE 
FD&C BLUE NO. 1 
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYDEXTROSE 
POLYSORBATE 80 
POVIDONES 
STARCH, CORN 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
FERRIC OXIDE YELLOW 
ZINC STEARATE 
Product Characteristics
ColorBLUE (light blue) Scoreno score
ShapeRECTANGLE (oblong shaped tablet) Size17mm
FlavorImprint CodeEXPM
Contains    
Packaging
#Item CodePackage Description
1NDC:0067-2056-241 BOTTLE in 1 CARTON
124 TABLET, COATED in 1 BOTTLE
2NDC:0067-2056-911 BOTTLE in 1 CARTON
2100 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/24/2014
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.

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