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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. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. 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.
  • 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

Ask a doctor or pharmacist before use if you are 

taking the blood thinning drug warfarin

Stop use and ask a doctor if
  • 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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.

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

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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

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.

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 Liver 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

    Children under 12 years: ask a doctor

Directions (For Pain Relief PM)
  • do not use more than directed (see Liver 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

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*, 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 Tylenol®

PAIN RELIEF

EXTRA STRENGTH

Acetaminophen

PAIN RELIEVER - FEVER REDUCER

Actual Size

See New Warnings and Directions

500 mg Each

VALUE PACK - DAY & NIGHT RELIEF

Compare to the Active Ingredients in Tylenol® PM

Extra Strength

PAIN RELIEF PM

PAIN RELIEVER - NIGHTTIME SLEEP-AID

Acetaminophen

Diphenhydramine HCl

Actual Size

Pain Relief and Pain Relief PM Carton Image 1

Pain Relief and Pain Relief PM Carton Image 2

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 (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 
POVIDONE 
SODIUM METABISULFITE 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (Caplet) Size16mm
FlavorImprint CodeL484
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-484-781 BOTTLE (BOTTLE) in 1 CARTON
1100 TABLET (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 GLYCOL 
POLYSORBATE 80 
POVIDONE 
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 (BOTTLE) in 1 CARTON
1100 TABLET, FILM COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33804/13/2004
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33809/30/2006
Labeler - American Sales Company (809183973)

Revised: 02/2012
 
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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