CAREONE ACETAMINOPHEN- acetaminophen tablet, coated

CareOne Acetaminophen by

Drug Labeling and Warnings

CareOne Acetaminophen by is a Otc medication manufactured, distributed, or labeled by American Sales Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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.

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 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

Other information

• store at 20-25°C (68-77°F)

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

ACETAMINOPHEN

500mg

Actual Size

OUR PHARMACISTS RECOMMEND

Pain Reliever/Fever Reducer

Easy to Swallow

For Adults

Gluten Free

50 GELTABS

INGREDIENTS AND APPEARANCE

CAREONE ACETAMINOPHEN 
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-844
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	YELLOW, RED	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	L187
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-844-78	1 in 1 CARTON	08/23/2016
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 41520-844-71	1 in 1 CARTON	09/21/2016
2		50 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	08/23/2016

Labeler - American Sales Company (809183973)