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Care One pain relief extra strength

Medically reviewed on February 23, 2018

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: American Sales Company
NDC Code: 41520-187

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 Drug Facts

Active ingredient (in each geltab)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses
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

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.
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 for more than 10 days
fever gets worse or lasts for 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.

Directions
do not take more than directed (see overdose warning)

adults and children 12 years and over

take 2 geltabs every 6 hours while symptoms last
do not take more than 6 geltabs 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

Inactive ingredients

corn starch*, croscarmellose sodium*, D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, titanium dioxide

*Contains one or more of these ingredients

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Extra Strength Tylenol®

Extra Strength

PAIN RELIEF

PAIN RELIEVER – FEVER REDUCER

Acetaminophen

Actual Size

Easy to Swallow

For Adults

See New Warnings

50 GELTABS

500 mg Each

CARE ONE PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-187
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
EDETATE DISODIUM 
GELATIN 
GLYCERIN 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
POVIDONES 
STEARIC ACID 
TITANIUM DIOXIDE 
STARCH, CORN 
Product Characteristics
ColorYELLOW, REDScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeL187
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-187-781 BOTTLE in 1 CARTON
1100 TABLET, COATED in 1 BOTTLE
2NDC:41520-187-711 BOTTLE in 1 CARTON
250 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/25/2003
Labeler - American Sales Company (809183973)

 
American Sales Company

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Further information

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

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