Acetaminophen by TOPCO ASSOCIATES LLC ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each gelcap)

Acetaminophen USP, 500 mg.

Purpose

Pain reliever/fever reducer

Uses

 temporarily relieves minor aches and pains due to:
 headache

 muscular aches
 backache

 minor pain of arthritis
 the common cold

 toothache
 premenstrual and menstrual cramps
 temporarily reduces fever

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 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

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

Drug Facts (continued)
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 at 20°-25°C (68°-77°F)
 avoid high humidity
 see end panel for expiration date and lot number

Inactive ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, p ovidone k-30, pregelatinized starch, propylene glycol, red iron oxide, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide

Questions or comments?

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Principal Display Panel

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-665
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SHELLAC (UNII: 46N107B71O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
STARCH, CORN (UNII: O8232NY3SJ)
AMMONIA (UNII: 5138Q19F1X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE K30 (UNII: U725QWY32X)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
STEARIC ACID (UNII: 4ELV7Z65AP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Product Characteristics
Color	gray (Encapsulated with red opaque and blue gray opaque hard gelatin shells)	Score	2 pieces
Shape	OVAL	Size	19mm
Flavor		Imprint Code	G1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-665-21	225 in 1 BOTTLE; Type 0: Not a Combination Product	10/14/2024
2	NDC: 36800-665-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/14/2024
3	NDC: 36800-665-40	400 in 1 BOTTLE; Type 0: Not a Combination Product	10/14/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	10/14/2024

Labeler - TOPCO ASSOCIATES LLC (006935977)