REGULAR STRENGTH PAIN RELIEF- acetaminophen tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Acetaminophen 325 mg
Available from:
Preferred Pharmaceuticals Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain Reliever/Fever Reducer
Authorization status:
OTC monograph not final
Authorization number:
68788-7359-1, 68788-7359-3, 68788-7359-6, 68788-7359-9

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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gc 102

Active Ingredients

Acetaminophen 325 mg

Purpos e

Pain Reliever/Fever Reducer

Us es

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:

in 24 hours

this product

Allergy alert: acetaminophen may cause severe skin

reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

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.

temporarily relieves minor aches and pains

temporarily reduces fever

more than 12 tablets (4,000 mg of acetaminophen)

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using

skin reddening

blisters

rash

with any other drug containing acetaminophen (prescription or nonprescription). If you are not

sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Stop use and ask a doctor if

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

Other Information

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.

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

new symptom occurs

redness or swelling is present

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

store at 20 C-25 C (68 F-77 F)

REGULAR STRENGTH PAIN RELIEF

acetaminophen tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 78 8 -7359 (NDC:578 9 6 -10 2)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

Inactive Ingredients

Ingredient Name

Stre ng th

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

GC10 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 78 8 -7359 -3

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /21/20 19

2

NDC:6 8 78 8 -7359 -6

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /21/20 19

3

NDC:6 8 78 8 -7359 -9

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /21/20 19

Preferred Pharmaceuticals Inc.

4

NDC:6 8 78 8 -7359 -1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /21/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 8 /21/20 19

Labeler -

Preferred Pharmaceuticals Inc. (791119022)

Registrant -

Preferred Pharmaceuticals Inc. (791119022)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Preferred Pharmaceuticals Inc.

79 1119 0 22

REPACK(6 8 78 8 -7359 )

Revised: 2/2020

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