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

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

Buy It Now

Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)
Available from:
National Distribution Network (Smart Choice)
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Cough suppressant Antihistamine temporarily relieves these common cold/flu symptoms: - minor aches and pains - headache - sore throat - fever - runny nose and sneezing - itchy nose or throat - coughs - cough due to minor throat and bronchial irritation
Authorization status:
OTC monograph final
Authorization number:
53441-346-06

NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine

succinate liquid

National Distribution Network (Smart Choice)

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.

----------

Drug Facts

Active ingredients (in each 30 mL, 2 tablespoons)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpos es

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Us es

temporarily relieves these common cold/flu symptoms:

minor aches and pains

headache

sore throat

fever

runny nose and sneezing

itchy nose or throat

coughs

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 doses ( 8 tablespoons or 120 mL) 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

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

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

Do not use

to make a child sleepy

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.

with any other drug containing acetaminophen (prescription or non-prescription). 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

glaucoma

breathing problems

chronic bronchitis

a sodium-restricted diet

trouble urinating due to an enlarged prostate gland

persistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is

accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking

sedatives or tranquilizers

the blood thinning drug warfarin

When using this product

do not use more than directed (see overdose warning)

excitability may occur, especially in children

marked drowsiness may occur

avoid alcoholic drinks

be careful when driving a motor vehicle or operating machinery

alcohol, sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

redness or swelling is present

new symptoms occur

fever gets worse or lasts more than 7 days

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.

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 (1-800-222-1222) 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

take only as recommended (see overdose warning)

do not exceed 4 doses per 24 hours

use dosing cup provided

tbsp=tablespoon, mL= milliliter

dose

adults & children 12 years &

over

2 tablespoons (30 mL) every 6 hours

children 4 to 11 years

do not use unless directed by a doctor

children under 4 years

do not use

When using other Day Time or Night Time products, carefully read each label to insure

correct dosing

Other information

each 30 mL contains; potassium 10 mg, sodium 38 mg

store at room temperature

Inactive ingredients

acesulfame potassium, alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6, high

fructose corn syrup, natural & artificial flavor, polyethylene glycol 300, propylene glycol, purified

water, saccharin sodium, sodium citrate

Principal Display Panel

Compare to the active ingredients in Vicks® NyQuil®*

Night Time

Cold & Flu

Acetaminophen-Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Doxylamine succinate -Antihistamine

Aches, fever, cough, runny nose and sneezing

for ages 12 and over

alcohol 10%

FL OZ (mL)

Original Flavor

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered

trademark Vicks® NyQuil®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.

DISTRIBUTED BY

NATIONAL DISTRIBUTION NETWORK

P.O. BOX 875

MELVILLE, NY 11747-0875

Product Label

Smart Choice Nig ht Time Cold and Flu

NIGHTTIME COLD AND FLU

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:53441-346

Route of Administration

ORAL

National Distribution Network (Smart Choice)

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

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

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

WATER (UNII: 0 59 QF0 KO0 R)

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

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

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

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

PO LYETHYLENE GLYCO L 3 0 0 (UNII: 56 55G9 Y8 AQ)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:53441-346 -0 6

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

0 6 /30 /20 14

0 1/31/20 20

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 /30 /20 14

0 1/31/20 20

Labeler -

National Distribution Network (Smart Choice) (045099210)

Revised: 4/2019

Similar products

Search alerts related to this product

View documents history

Share this information