American Sales Company Pain Relief Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

CARE ONE PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet 
American Sales Company

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.

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American Sales Company Pain Relief Drug Facts

Active ingredient (in each caplet)

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 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

Other information

• store at 20-25ºC (68-77ºF)

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Tylenol®

Extra Strength

PAIN RELIEF

PAIN RELIEVER – FEVER REDUCER

Acetaminophen

For Adults

100 CAPLETS

500 mg Each

Actual Size

See New Warnings

CARE ONE PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-484
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE (caplet)	Size	16mm
Flavor		Imprint Code	L484
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-484-71	1 in 1 CARTON	04/13/2004	08/03/2019
1		50 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 41520-484-78	1 in 1 CARTON	04/13/2004	09/03/2019
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 41520-484-90	500 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2004	07/02/2019
4	NDC: 41520-484-76	1 in 1 CARTON	04/13/2004	05/09/2018
4		120 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 41520-484-82	2 in 1 CARTON	04/13/2004	09/03/2019
5		100 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	04/13/2004	09/03/2019

Labeler - American Sales Company (809183973)

Revised: 12/2018

Document Id: 20af7c33-5019-4a11-a592-46c498f85bea

34390-5

Set id: 5f21add1-22a3-43d8-85f1-6d4f3f799d6a

Version: 6

Effective Time: 20181215