NEXT NIGHT SEVERE COLD, FLU AND SORE THROAT- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride liquid

Next Night Severe Cold, Flu and Sore Throat by

Drug Labeling and Warnings

Next Night Severe Cold, Flu and Sore Throat 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 30mL dose cup or 2 tablespoons)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine Succinate 12.5 mg
Phenyleprine HCL 10 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal Decongestant

Uses

Temporarily relieves cold/flu symptoms:

• nasal congestion
• sinus congestion & pressure
• sore throat
• headache
• minor aches and pain
• runny nose and sneezing
• temporarily reduces fever
• cough due to minor throat and bronchial irritation
• promotes nasal and/or sinus drainage

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 vomitting, consult a doctor promptly.

Do not use

• with any other drug containing acetaminophen (prescription or non prescription). 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

• a sodium restricted diet
• liver disease
• heart disease
• glaucoma
• high blood pressure
• thyroid disease
• diabetes
• cough that occurs with too much phlegm (mucus)
• a breathing problems 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 tranquillizers
• taking the blood thinning drug warfarin.

When using this product

• do not use more than directed
• avoid alcoholic drinks
• marked drowsiness may occur
• excitability may occur especially in children
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• redness or swelling is present
• pain, nasal congestion, or cough gets worse or lasts more tha 7 days
• fever gets worse or lasts more than 3 days
• 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.

Keep out of reach of children.

In case of overdose,

get medical help or contact a Poison Control Center right away. Quick medical atttention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as recommended. See Warnings
• use dose cup or tablespoon (TBSP)
• do not exceed 4 doses per 24 hours

Age                                             Dose

Adults & chilren 12 years             30 mL (2 TBSP)
and over                                     every 4 hours

Children 4 to 12 years                 Ask a doctor             

Children under 4 years                 Do not use

• if taking other cold/flu products, read labels before dosing

Other information

• each 30 mL contains: sodium 45 mg
• store at room temperature
• keep carton for future reference

Inactive ingredients

Citric acid, FD&C Blue # 1, FD&C Red #40, Flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sorbitol, xanthan gum

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-99 GENOM (4366)

Next Night Severe Cold, Flu & Sore Throat product label

TAMPER EVIDENT. DO NOT USE IF SAFETY SEAL UNDER CAP IS MISSING OR BROKEN

NEXT Night

NEW MAX STRENGTH

Severe

Cold, Flu &
Sore Throat

• Fever, Aches & Pains
• Runny Nose, Nasal Congestion
  & Sinus Pressure
• Cough

Acetaminophen
Pain Reliever - Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Doxylamine succinate Antihistamine
Phenylephrine HCL Nasal Decogestant

BERRY FLAVOR

6 FL OZ (177 mL)

Distributed byy
Genomma Lab USA Inc., Houston, X 77027

BX-059

INGREDIENTS AND APPEARANCE

NEXT NIGHT SEVERE COLD, FLU AND SORE THROAT 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-540
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	10 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-540-25	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/02/2016

Labeler - Genomma Lab USA, Inc. (832323534)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(50066-540)