Extra Strength Acetaminophen by Bene Health OTC / Geri-Care Pharmaceutical Corp ben 204

Drug Details [pdf]

EXTRA STRENGTH ACETAMINOPHEN- acetaminophen tablet
Bene Health OTC

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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ben 204

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. The
maximum daily dose of this product is 6 tablets in 24 hours.
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 1-2 tablets every 4-6 hours, as needed. Do not take more than 6
tablets in 24 hours, unless directed by a doctor.
children under 12 years: do not use

Other Information

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive Ingredients

povidone, sodium starch glycolate, starch, stearic acid.

201

EXTRA STRENGTH ACETAMINOPHEN
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65155-204
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 65155-204-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	02/01/2020	05/01/2022

Labeler - Bene Health OTC (830110347)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Name	Address	ID/FEI	Business Operations
Establishment
Geri-Care Pharmaceutical Corp		611196254	pack(65155-204)

Revised: 12/2021

Document Id: d22eb658-97a5-15f6-e053-2a95a90a5345

Set id: a7aaeb85-f296-7c35-e053-2995a90a0cee

Version: 2

Effective Time: 20211202