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Drug Labeling and Warnings

Drug Details

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REGULAR STRENGTH PAIN RELIEF- acetaminophen tablet 
Preferred Pharmaceuticals Inc.

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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Active Ingredients

Acetaminophen 325 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 10 tablets
in 24 hours. Severe liver damage may occur if you take:

• more than 12 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 4-6 hours, as needed; not more than 10 tablets in 24 hours
• children under 12 years: ask a doctor

Other Information

• store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive Ingredients

povidone, sodium starch glycolate, starch stearic acid.

Package Label

Gericare

NDC: 68788-7359

Regular Strength

ACETAMINOPHEN

Pain Reliever / Fever Reducer

*Compare to active ingredient in the Regular Strength Tylenol tablets

package not child resistant

325 mg each

Dist. by: Gericare Pharmaceuticals Corp.

1650 63rd street

Brooklyn, NY 11204

Repackaged by Preferred Pharmaceuticals, Inc.

REGULAR STRENGTH PAIN RELIEF 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-7359(NDC: 57896-102)
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
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	GC101
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-7359-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/21/2019
2	NDC: 68788-7359-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	08/21/2019
3	NDC: 68788-7359-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	08/21/2019
4	NDC: 68788-7359-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	08/21/2019

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	REPACK(68788-7359)

Revised: 8/2019

Document Id: f5758d39-7f9d-4092-a8ae-aa28a0439d39

34390-5

Set id: f5758d39-7f9d-4092-a8ae-aa28a0439d39

Version: 1

Effective Time: 20190821

 

Preferred Pharmaceuticals Inc.