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care one pain relief pm extra strength

Medically reviewed on March 6, 2018

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: American Sales Company
NDC Code: 41520-837

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.

American Sales Company Pain Relief PM Drug Facts

Active ingredient (in each geltab)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

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 have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have
liver disease
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma

Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
taking 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
sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur

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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 and over

take 2 geltabs at bedtime
do not take more than 2 geltabs of this product in 24 hours

children under 12 years

do not use

Inactive ingredients

crospovidone, D&C red #33 aluminum lake, edetate disodium, edible ink, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the Active Ingredients in Extra Strength Tylenol® PM

Extra Strength

PAIN RELIEF PM

PAIN RELIEVER – NIGHTTIME SLEEP-AID

Acetaminophen

Diphenhydramine HCl

Actual Size

For Adults

Non-Habit Forming

See New Warnings

50 GELTABS

CARE ONE PAIN RELIEF PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-837
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
CROSPOVIDONE 
EDETATE DISODIUM 
GELATIN 
GLYCERIN 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
STEARIC ACID 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorBLUE, WHITEScoreno score
ShapeROUND (Convex) Size12mm
FlavorImprint CodeL837
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-837-711 BOTTLE in 1 CARTON
150 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/13/2004
Labeler - American Sales Company (809183973)

 
American Sales Company

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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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