NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan, doxylamine 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 HealthLife of USA, Softech Pharma Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

(in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine Succinate 6.25 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

temporarily relieves common cold and flu symptoms:

• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and 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 hours, which is the maximum daily amount for this productwith 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 followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• with any other products 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 drugs. 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 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 exceed recommended dosage
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drink
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and 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 last 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.

Keep out of reach of children.

If pregnant or breast-feeding, ask a health professional before use.

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. 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 for children even if you do not notice any signs or symptoms.

Direction

• take only as directed – see overdose warning
  
• do not exceed 4 doses per 24 hours
• Adults and children 12 years and over: 2 softgels with water every 4 hours
• children 4 to under 12 years: ask a doctor
• Children under 4 years: do not use

Other Information

• store at room temperature.
• read all product information before using.
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive Ingredients

D&C Yellow No.10, FD&C Blue No. 1, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol, Titanium dioxide

Questions or Comments

1-844-832-1138 (Mon-Fri 9AM-5PM EST) or www.healthlifeofusa.com

PACKAGE LABEL

*This product is not manufactured or distributed by the Procter & Gamble Company. Vicks®, NyQuil®, and LiquiCaps® are registered trademark of the Procter & Gamble Company.

NDC: 69517-103-16   16 softgels

NDC: 69517-103-10   10 softgels

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-103
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	10 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 (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	215
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-103-16	16 in 1 BOTTLE; Type 0: Not a Combination Product	08/26/2015
2	NDC: 69517-103-10	1 in 1 CARTON	06/09/2017
2		10 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 final	part341	08/26/2015

Labeler - HealthLife of USA (079656178)

Registrant - HealthLife of USA (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
Softech Pharma Pvt. Ltd		677111277	manufacture(69517-103)