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

Nighttime Cold and flu Relief by

Drug Labeling and Warnings

Nighttime Cold and flu Relief by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (In each capsule)

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 & 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 alcohol drinks daily while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
• to make a child sleep

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 an 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 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.

Over dose warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & 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 hours 
  • adults & children 12 yrs & over: 2 capsules with water every 6 hrs
  • children 4 to under 12 yrs: ask a doctor
  • children under 4 yrs: do not use
• when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

• store at controlled room temperature 15°C to 30°C (59°F to 86°F)
• avoid excessive heat

Inactive ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerine, polyethylene glycol 400, povidone K12, propylene glycol, purified water, sorbitol sorbitan solution, white ink.

Questions or comments?

Call 1-800-706-5575

Principal Display Panel

Premier Value

Multi-Symptom

Nighttime Cold/Flu Relief

NDC number 68016-599-16

16 Softgel

16 Liquid Capsule

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-599
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, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K12 (UNII: 333AG72FWJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	94A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-599-16	8 in 1 BLISTER PACK	10/12/2015	07/31/2021
1		2 in 1 CARTON; Type 0: Not a Combination Product
2	NDC: 68016-599-24	12 in 1 BLISTER PACK	10/12/2015	07/31/2021
2		2 in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/12/2015	07/31/2021

Labeler - Chain Drug Consortium, LLC (101668460)