COLD AND FLU NIGHTTIME- acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)
Available from:
Bi-Mart
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Cough suppressant Antihistamine - temporarily relieves common cold and flu symptoms: runny nose and sneezing fever sore throat headache minor aches and pains cough due to minor throat and bronchial irritation - runny nose and sneezing - fever - sore throat - headache - minor aches and pains - cough due to minor throat and bronchial irritation
Authorization status:
OTC monograph final
Authorization number:
37835-524-30

COLD AND FLU NIGHTTIME- acetaminophen, dextromethorphan hbr, doxylamine

succinate liquid

Bi-Mart

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.

----------

Bi-Mart 44-014

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold and flu symptoms:

runny nose and sneezing

fever

sore throat

headache

minor aches and pains

cough due to minor throat and bronchial irritation

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.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or

followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after

stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a

doctor or pharmacist before taking this product.

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

difficulty in urination due to enlargement of the prostate gland

cough that occurs with too much phlegm (mucus)

a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic

bronchitis, or emphysema

liver disease

glaucoma

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage

excitability may occur, especially in children

avoid alcoholic beverages

marked drowsiness may occur

alcohol, sedatives, and tranquilizers may increase drowsiness

use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

pain or cough gets worse or lasts more than 7 days

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

cough comes back or occurs with rash or headache that lasts. 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

mL = milliliter; FL OZ = fluid ounce

use only enclosed dosing cup designed for use with this product. Do not use any other dosing

device.

do not take more than 4 doses per 24 hours

adults and children 12 years and over: 30 mL every 6 hours

children under 12 years: do not use

Other information

each 30 mL contains: sodium 18 mg

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

use by expiration date on package

Inactive ingredients

anhydrous citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6, flavors, glycerin, high

fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium

chloride, sodium citrate dihydrate, sodium saccharin, sucralose

Questions or comments?

1-800-935-6737

Principal Display Panel

BI-MART

Compare to the active ingredients in Vicks® NyQuil® Cold & Flu Nighttime Relief*

NIGHTTIME

COLD & FLU

Acetaminophen (Pain reliever/fever reducer)

Dextromethorphan HBr (Cough suppressant)

Doxylamine succinate (Antihistamine)

Multi-Symptom Relief

Aches, Fever & Sore Throat

Cough

Sneezing, Runny Nose

Alcohol Free

12 FL OZ (354 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING

This product is not manufactured or distributed by Procter & Gamble distributor of Vicks® NyQuil®

Cold & Flu Nighttime Relief.

50844 ORG031801402

Distributed by:

BI-MART

Eugene, OR 97402

PARENTS:

Learn About Teen Medicine Abuse

www.StopMedicineAbuse.org

Bi-Mart 4 4 -014

COLD AND FLU NIGHTTIME

acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:378 35-524

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

6 50 mg

in 30 mL

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

30 mg

in 30 mL

DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DOXYLAMINE -

UNII:9 5QB77JKPL)

DOXYLAMINE SUCCINATE

12.5 mg

in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C GREEN NO . 3 (UNII: 3P3ONR6 O1S)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

GLYCERIN (UNII: PDC6 A3C0 OX)

HIGH FRUCTO SE CO RN SYRUP (UNII: XY6 UN3QB6 S)

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

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

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Product Characteristics

Color

GREEN

S core

S hap e

S iz e

Flavor

MINT (Eucalyptus)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:378 35-524-30

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

0 6 /18 /20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 6 /18 /20 18

Labeler -

Bi-Mart (027630078)

Bi-Mart

Labeler -

Bi-Mart (027630078)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

MANUFACTURE(378 35-524) , PACK(378 35-524)

Revised: 5/2020

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