NEXT SEVERE COLD, FLU AND SORE THROATE NIGHT MAX STRENGTH- acetaminophen, dextromethorphan hbr, doxylamine succinate, and phenylephrine hcl solution

NEXT Severe Cold, Flu and Sore Throate Night Max Strength by

Drug Labeling and Warnings

NEXT Severe Cold, Flu and Sore Throate Night Max Strength by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA Inc, Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients
(in each 30 mL dose cup)

Acetaminophen USP 650 mg
Dextromethorphan HBr USP 20 mg
Doxylamine succinate USP 12.5 mg
Phenylephrine HCl USP 10 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

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 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
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• 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
• a sodium-restricted diet

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 and ask a doctor if

• you get nervous, dizzy or sleepless
• pain, nasal congestion, 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.

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 (1-800-222-1222). Prompt 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 Overdose warning
• use dose cup or tablespoon (TBSP)
• do not exceed 4 doses per 24 hours
• mL = milliliter; TBSP = tablespoon

• adults & children 12 years & over: 30 mL (2 TBSP) every 4 hours
• children 4 to under 12 years: ask a doctor
• children under 4 years: do not use

• when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

• each 30 mL dose cup contains: sodium 95 mg
• store at 20° to 25°C (68° to 77°F)
• keep carton for future reference

Inactive ingredients

anhydrous citric acid, flavors, FD&C Blue no. 1, FD&C Red no. 40, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or Comments?

call 1 877 99 GENOM (43666) (Monday - Friday 8:30 AM to 5:00 PM EST)

Distributed by:
Genoma Laba USA Inc.,
Houston, TX 77027

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 6 FL OZ (177 mL Carton Label)

MAX STRENGTH

NEXT

Night

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 decongestant

Berry Flavor                           

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

NEXT SEVERE COLD, FLU AND SORE THROATE NIGHT MAX STRENGTH 
acetaminophen, dextromethorphan hbr, doxylamine succinate, and phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-926
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 HYDROCHLORIDE	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)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	BERRY (Prosweet) , MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-926-18	1 in 1 CARTON	06/21/2018
1		177 mL in 1 BOTTLE; 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	06/21/2018

Labeler - Genomma Lab USA Inc (832323534)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(50066-926)