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Care One Pain Relief and Pain Relief PM

Dosage form: kit
Ingredients: ACETAMINOPHEN 500mg; ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: American Sales Company
NDC Code: 41520-969

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 and Pain Relief PM Drug Facts

Active ingredient (in each caplet) (For Pain Relief)

Acetaminophen 500 mg

Active ingredient (in each caplet) (For Pain Relief PM)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose (For Pain Relief)

Pain reliever/fever reducer

Purpose (For Pain Relief PM)

Pain reliever

Nighttime sleep aid

Uses (For Pain Relief)
temporarily relieves minor aches and pains due to:
the common cold
headache
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever

Uses (For Pain Relief PM)

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

Warnings (For Pain Relief)

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.

Warnings (For Pain Relief PM)

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 (For Pain Relief)
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you have ever had an allergic reaction to this product or any of its ingredients

Do not use (For Pain Relief PM)
in children under 12 years of age
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
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have (For Pain Relief)

liver disease

Ask a doctor before use if you have (For Pain Relief PM)
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 (For Pain Relief)

taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are (for Pain Relief PM)
taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product (For Pain Relief PM)
drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if (For Pain Relief)
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

Stop use and ask a doctor if (For Pain Relief PM)
sleeplessness persists 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, (For Pain Relief)

ask a health professional before use.

If pregnant or breast-feeding, (For Pain Relief PM)

ask a health professional before use.

Keep out of reach of children. (For Pain Relief)

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.

Keep out of reach of children. (For Pain Relief PM)

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 (For Pain Relief)
do not take more than directed (see overdose warning)
Adults and children 12 years and over:
take 2 caplets every 6 hours while symptoms last
do not take more than 6 caplets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor

Children under 12 years: ask a doctor

Directions (For Pain Relief PM)
do not take more than directed (see overdose warning)
Adults and children 12 years and over:
take 2 caplets at bedtime
do not take more than 2 caplets of this product in 24 hours

Children under 12 years: do not use

Other information (For Pain Relief and Pain Relief PM)
store at 20-25°C (68-77°F)

Inactive ingredients (For Pain Relief)

carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

Inactive ingredients (For Pain Relief PM)

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? (For Pain Relief and Pain Relief PM)

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Extra Strength Tylenol® Caplets

Extra Strength

PAIN RELIEF

PAIN RELIEVER - FEVER REDUCER

Acetaminophen

For Adults

Actual Size

See New Warnings

100 CAPLETS 500 mg Each

VALUE PACK - DAY & NIGHT RELIEF

Compare to the Active Ingredients in Extra Strength Tylenol® PM Caplets

Extra Strength

PAIN RELIEF PM

PAIN RELIEVER - NIGHTTIME SLEEP-AID

Acetaminophen

Diphenhydramine HCl

Actual Size

For Adults

Non-Habit Forming

See New Warnings

100 CAPLETS

CARE ONE PAIN RELIEF AND PAIN RELIEF PM 
acetaminophen, diphenhydramine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-969
Packaging
#Item CodePackage Description
1NDC:41520-969-091 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 100 
Part 21 BOTTLE 100 
Part 1 of 2
CARE ONE PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet
Product Information
Item Code (Source)NDC:41520-484
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
POVIDONES 
SODIUM METABISULFITE 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (Caplet) Size16mm
FlavorImprint CodeL484
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-484-781 BOTTLE in 1 CARTON
1100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/13/2004
Part 2 of 2
CARE ONE PAIN RELIEF PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, film coated
Product Information
Item Code (Source)NDC:41520-437
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 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONES 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUE (Light blue) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeL437;PM
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-437-781 BOTTLE in 1 CARTON
1100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/13/2004
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/30/2006
Labeler - American Sales Company (809183973)

Revised: 02/2016
 
American Sales Company

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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