ACETAMINOPHEN REGULAR STRENGTH- acetaminophen tablet

Acetaminophen Regular Strength by

Drug Labeling and Warnings

Acetaminophen Regular Strength by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains associated with:
• headache
• muscular aches 
• backache
• arthritis
• common cold
• toothache
• menstrual cramps
• temporarily reduces fever

Warnings

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

• more than 8 caplets in 24 hours, which is the maximum daily amount 
• with other drugs containing acetaminophen 
• 3 or more alcoholic drinks every day while using this product

Do not use

• with any other drugs 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

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days. 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: Taking more than the recommended dose (overdose) may cause liver damage. 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 (see overdose warning)

• adults and children 12 years and over:
  • take 2 tablets every 4 to 6 hours as needed
  • do not take more than 8 tablets in 24 hours
  • do not take for more than 10 days unless directed by a doctor
• children 6-11 years:
  • take 1 tablets every 4 to 6 hours as needed
  • do not take more than 4 tablets in 24 hours
  • do not take for more than 5 days unless directed by a doctor
• children under 6 years: do not use this adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

• store at room temperature. Protect from moisture. 
• avoid excessive heat 40ºC (above 104º F)

Inactive ingredients

Corn starch, pregelatinized starch, stearic acid, may contain povidone, sodium starch glycolate

Questions?

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Acetaminophen Regular Strength

GENERIC: ACETAMINOPHEN

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-3416-0

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 11 mm

IMPRINT: AZ010

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• ACETAMINOPHEN 325mg in 1

INACTIVE INGREDIENT(S):

• STEARIC ACID
• STARCH, CORN

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN REGULAR STRENGTH 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-3416(NDC:54257-720)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AZ010
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-3416-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	05/05/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/05/2022

Labeler - REMEDYREPACK INC. (829572556)