EXTRA STRENGTH ACETAMINOPHEN- acetaminophen tablet

Extra Strength Acetaminophen by

Drug Labeling and Warnings

Extra Strength Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

• temporarily relieves minor aches and pains
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:

• more than 8 tablets (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.

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 symptom 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. 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
• adults and children 12 years and over: Take 2 tablets every 6 hours, as needed; not more than 6 tablets in 24 hours. Do
  not take for more than 10 days unless directed by a doctor.
• children under 12 years: ask a doctor

Other Information

• store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive Ingredients

povidone, sodium starch glycolate, starch, stearic acid.

Questions or comments?

1-800-540-3765

HOW SUPPLIED

Acetaminophen 500 mg

NDC: 72162-2179-1: 100 Tablets in a BOTTLE

store at 20⁰C-25⁰C (68⁰F-77⁰F)

Repackaged/Relabeled by:
Bryant Ranch Prepack
Burbank, CA 91504

PRINCIPAL DISPLAY PANEL

Acetaminophen 500mg Tablets #100

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72162-2179(NDC:57896-204)
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)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (WHITE)	Score	no score
Shape	ROUND (Round)	Size	12mm
Flavor		Imprint Code	AZ011
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72162-2179-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2018	02/28/2027

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/01/2018	02/28/2027

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(72162-2179) , RELABEL(72162-2179)