NEXT COLD AND FLU NIGHTTIME- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, gelatin coated

NEXT COLD and FLU by

Drug Labeling and Warnings

NEXT COLD and FLU by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA, Inc., AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive 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 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 cantains acetaminophen. Severe liver damage may occur if you take

• more than 4 doses in 24 hours, which is the maxium daily amount
• 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 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 an MAOI drug. If you do not know if 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 lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts
• a skin reaction occurs. 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.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center 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

• take only as directed (see Warnings)
• do not exceed 4 doses per 24 hours
• Adults and children 12 years and over:
  take 2 softgels with water every 6 hours
• Children 4 to under 12 years: Ask a doctor

Children under 4 years: Do not use

• When using Day Time ot Night Time products, carefully read each label to ensure correct dosing

Other information

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

Inactive Ingredients

FD&C Blue # 1, D&C Yellow # 10, Gelatin, Glycerin, Polyethylene glycol, Povvidone, Propylene glycol, Purified water, Sorbital sorbitan solution, Titanium dioxide.

Questions?

Call 1-877-99-Genom (43666)
Weekdays from 8am to 6 pm

NEXT COLD & FLU NIGHTTIME product label

NEXT
COLD & FLU

NIGHTTIME RELIEF

• Fever
• Sneezing
• Sore Throat
• Aches
• Runny Nose
• Cough

Acetaminophen/
Dextromethorphan HBr / Doxylamine succinate

Tamper evident: Do not use if blisters are torn or open

Distributed by:
Genomma Lab USA, Inc.
Houston, TX 77027

Made in India

BX-056

INGREDIENTS AND APPEARANCE

NEXT COLD AND FLU  NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-603
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
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	OVAL	Size	21mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-603-03	24 in 1 BOX	05/03/2016
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 final	part341	05/03/2016

Labeler - Genomma Lab USA, Inc. (832323534)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(50066-603) , relabel(50066-603) , repack(50066-603)