ACETAMINOPHEN tablet, coated

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Harris Teeter. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each gelcap)

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

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 are allergic to acetaminophen or any of the inactive ingredients in this product

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 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps 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 between 20-25ºC (68-77ºF)
• retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

Harris Teeter

Rapid Release

Acetaminophen

Compare to the Active Ingredient in Tylenol(R) Extra Strength Rapid Release Gels

Extra Strength, 500 mg

PAIN RELIEVER / FEVER REDUCER

Contains No Aspirin

Fast Release

50 Rapid Release Gelcaps

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72036-170
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	gray (red and light blue ends)	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	G1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72036-170-02	1 in 1 CARTON	06/06/2016
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 72036-170-03	1 in 1 CARTON	06/06/2016
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 72036-170-05	1 in 1 CARTON	06/06/2016
3		225 in 1 BOTTLE, PLASTIC; 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	06/06/2014

Labeler - Harris Teeter (047279351)