NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, 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:
CVS Pharmacy
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
 Pain reliever/Fever Reduce r Cough suppressant Antihistamine - temporarily relieves common cold and flu symptoms: sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation - sore throat - headache - minor aches and pains - fever - runny nose and sneezing - cough due to minor throat and bronchial irritation
Authorization status:
OTC monograph final
Authorization number:
69842-899-16, 69842-899-24, 69842-899-48

NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM- acetaminophen,

dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

CVS Pharmacy

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 softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpos e

Pain reliever/Fever Reducer

Cough suppressant

Antihistamine

Us es

temporarily relieves common cold and flu symptoms:

sore throat

headache

minor aches and pains

fever

runny nose and sneezing

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 everyday 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 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 of pharmacist before taking this product.

Ask a doctor before use if you have

liver disease

glaucoma

trouble urinating due to an enlarged prostate gland

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

bronchitis or emphysema

cough that occurs with too much phlegm (mucus)

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 drinks

marked drowsiness may occur

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful 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.

Overdose warning: Taking more than the recommended dose can 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

do not take more than directed (see Overdose warning)

do not take more than 4 doses in 24 hours

adults and children 12 years and over: take 2 softgels with water every 6 hours

swallow whole; do not crush, chew, or dissolve

children under 12 years: do not use

when using other Daytime or Nighttime products, carefully read each label to insure correct

dos ing

Other information

store between 15-30ºC (59-86ºF)

avoid excessive heat

Inactive ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene

glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

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

Cold/Flu

Multi Symptom

Nighttime

Cold/Flu Relief

ACETAMINOPHEN - Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr - Cough suppressant

DOXYLAMINE SUCCINATE - Antihistamine

Relieves:

Aching, fever, sore throat, coughing, sniffling and sneezing so you can rest

SOFTGELS**

(**LIQUID-FILLED CAPSULES)

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®,

NyQuil®, and LiquiCaps® are registered trademark of the Procter & Gamble Company

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy, Inc

One CVS Drive, Woonsocket, RI 02895

Package Label

CVS HEALTH Multi-Symptom Nig httime Cold & Flu

NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-8 9 9

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

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

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

15 mg

DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DOXYLAMINE - UNII:9 5QB77JKPL)

DOXYLAMINE SUCCINATE

6 .25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

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

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

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)

CVS Pharmacy

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

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

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

MANNITO L (UNII: 3OWL53L36 A)

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

Product Characteristics

Color

GREEN

S core

no sco re

S hap e

OVAL

S iz e

21mm

Flavor

Imprint Code

PC10

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 8 42-8 9 9 -16

16 in 1 CARTON

0 7/31/20 19

1

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:6 9 8 42-8 9 9 -24

24 in 1 CARTON

0 7/31/20 19

2

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:6 9 8 42-8 9 9 -48

48 in 1 CARTON

0 7/31/20 19

3

1 in 1 BLISTER PACK; 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 FINAL

pa rt341

0 7/31/20 19

Labeler -

CVS Pharmacy (062312574)

Revised: 8/2019

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