PAIN RELIEVER- acetaminophen capsule, liquid filled

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
CHAIN DRUG MARKETING ASSOCIATION INC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps - headache - the common cold - backache - minor pain of arthritis - toothache - muscular aches - premenstrual and menstrual cramps - temporarily reduces fever
Authorization status:
OTC monograph not final
Authorization number:
63868-440-20

PAIN RELIEVER- acetaminophen capsule, liquid filled

CHAIN DRUG MARKETING ASSOCIATION 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.

----------

Quality Choice 44-718

Active ingredient (in each liquid-filled capsule)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

headache

the common cold

backache

minor pain of arthritis

toothache

muscular aches

premenstrual and menstrual cramps

temporarily reduces fever

Warnings

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

more than 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.

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

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

new symptoms 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222)

right away. Prompt 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 capsules every 4 to 6 hours while symptoms last

do not take more than 10 capsules in 24 hours, unless directed by a doctor

do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

Other information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

protect from heat, humidity and light

see end flap for expiration date and lot number

Inactive ingredients

edible white ink, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol,

purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

QC®

QUALITY

CHOICE

*Compare to the Active Ingredient in Tylenol® Regular Strength

Regular Strength

Pain Reliever

Acetaminophen 325 mg

Pain Reliever/Fever Reducer

20 Liquid-Filled Capsules actual size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS

BROKEN OR MISSING

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the

registered trademark Tylenol® Regular Strength.

50844 ORG011971809

Product of India

SATISFACTION

100% QC

GUARANTEED

Distributed by C.D.M.A., Inc.©

43157 W 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality Choice 4 4 -718

PAIN RELIEVER

acetaminophen capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 38 6 8 -440

Route of Administration

ORAL

Active Ingredient/Active Moiety

CHAIN DRUG MARKETING ASSOCIATION INC

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

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

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

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

Product Characteristics

Color

RED (clear)

S core

no sco re

S hap e

OVAL

S iz e

15mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 38 6 8 -440 -20

1 in 1 CARTON

0 7/29 /20 19

1

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

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part343

0 7/29 /20 19

Labeler -

CHAIN DRUG MARKET ING ASSOCIAT ION INC (011920774)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(6 38 6 8 -440 )

Revised: 6/2020

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