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

NightTime Cold and Flu by

Drug Labeling and Warnings

NightTime Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purpose

Pain reliever/Fever reducer
Cough suppressant
Antihistamine

Uses

temporarily relieves common cold/flu symptoms:  cough due to minor throat & bronchial irritation   sore throat  headache  minor aches & pains  fever  runny nose and sneezing

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
 more than 4 doses in 24 hrs, which is the maximum daily amount for this product
 with other drugs containing acetaminophen
 3 or more alcoholic drinks daily 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 monamine 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.

Ask a doctor before use if you have    liver disease    glaucoma    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    trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are
 taking sedatives or tranquilizers    taking the blood thinning drug warfarin

When using this product  do not use more than directed   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, & tranquilizers may increase drowsiness

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: In case of overdose, get medical help or contact a Poison Control Center right away.
Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

take only as directed - see overdose warning
do not exceed 4 doses per 24 hrs

• adults and children 12 yrs & over: 2 softgels with water every 6 hrs
• children 4 to under 12: ask a doctor
• children under 4 yrs: do not use

Other information

store at room temperature between 20-25°C (68-77°F)

Inactive ingredients

D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments

1-888-577-8033 Monday - Friday 8am - 4pm EST

SPL UNCLASSIFIED SECTION

Compare to the active ingredients of Vicks® NyQuil™ Cold & Flu Relief LiquiCaps™*

RIGHT REMEDIES

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by Procter & Gamble Company, owner of the registered trademarks Vicks® and NyQuil™.

Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

Product of UAE   

Packaged and Quality Assured in the USA

DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

REV.00-072022

Packaging

INGREDIENTS AND APPEARANCE

NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-808
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	808
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-808-48	4 in 1 CARTON	04/05/2023
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/05/2023

Labeler - Strive Pharmaceuticals Inc. (080028013)