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 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.. 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 warningThis 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 product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

Sore throat warningIf sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

DO NOT USE

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 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, and tranquilizers may increase drowsiness

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Overdose 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 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 hours

• adults and children 12 years of age and over: take 2 softgels with water every 6 hours
• children 4 to 12 years of age: ask a doctor
• children under4 years o9f age: do not use

When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing.

Other information

• store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

D&C Yellow # 10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei 430206,
China

PRINCIPAL DISPLAY PANEL - Shipping Label

NIGHTTIME COLD AND FLU CAPSULES

Quantity : 4000 Capsules
NDC. No : 53345-026-01

IMPORTANT:
1.Inspect immediately upon receipt.
2.This is a bulk shipment, intended for further processing only.
3.Protect from heat, humidity, and light. Do not refrigerate.
4.Store at 15-30°C (59-86°F)

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING"

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: 53345-026
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 (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	green	Score	no score
Shape	CAPSULE (oblong)	Size	21mm
Flavor		Imprint Code	660
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53345-026-01	1 in 1 BOX	08/11/2014
1		4000 in 1 BAG; 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	08/11/2014

Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.		421293287	MANUFACTURE(53345-026) , ANALYSIS(53345-026)