CHILDRENS NOVEX COLD PLUS COUGH PLUS SORE THROAT- acetaminophen and dextromethorphan hydrobromide suspension

Childrens Novex Cold Plus Cough Plus Sore Throat by

Drug Labeling and Warnings

Childrens Novex Cold Plus Cough Plus Sore Throat by is a Otc medication manufactured, distributed, or labeled by Herbion Pakistan (Pvt.) Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

(in each 5mL)
Acetaminophen 160 mg 

Dextromethorphan HBr 5 mg

PURPOSE

Purposes

Fever Reducer / Pain Reliever

Cough suppressant

INDICATIONS & USAGE

Uses
■ temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat cough
■ temporarily reduces fever

WARNINGS

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

■ more than 5 doses in 24 hours, which is the maximum daily amount
■ with other drugs containing acetaminophen

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.

ASK DOCTOR

Ask a doctor before use if your child has
■ liver disease ■ persistent or chronic cough such as occurs with asthma ■ cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

When using this product do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if
■ pain or cough gets worse or lasts more than 5 days
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present
■ cough comes back with rash or headache that lasts
These could be signs of a serious condition

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.
■ in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
■ if your child has ever had an allergic reaction to this product or any of its ingredients

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions
■ this product does not contain directions or complete warnings for adult use
■ do not give more than directed (see overdose warning)
■ shake well before using
■ mL = milliliter
■ find right dose on chart below. If possible, use weight to dose; otherwise, use age.
■ remove the child protective cap and squeeze your child's dose into the dosing cup
■ repeat dose every 4 hours, while symptoms last
■ do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL)*
Under 36	Under 4 years	Do not use
36-47	4-5 years	5 mL
48-95	6-11 years	10 mL

*or as directed by a dosctor

Attention: use only enclosed dosing cup provided, specifically designed for use with this product.

OTHER SAFETY INFORMATION

Other Information:

■ store between 68-770F (20-250C)
■ do not use if bottle cap seal is broken

INACTIVE INGREDIENT

Inactive Ingredients:

Carboxymethylcellulose sodium, FD&C Red No. 40, Flavor, Glycerin, Potassium Sorbate, Purified water, Sodium benzoate, Sorbitol solution, Sucrose, Sucralose, Xanthan gum

QUESTIONS

Questions or Comments?

Call 1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5pm EST

Children’s Novex Cough + Cold + Sore Throat Acetaminophen, Pain reliever-fever reducerDextromethorphan HBr, Cough suppressant Oral suspension FeverSore ThroatCough Ages: 4 to 11  Bubblegum Flavor 4 fl oz (120 ml)

INGREDIENTS AND APPEARANCE

CHILDRENS NOVEX COLD PLUS COUGH PLUS SORE THROAT 
acetaminophen and dextromethorphan hydrobromide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44237-043
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44237-043-03	1 in 1 CARTON	03/21/2020
1		120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/21/2020

Labeler - Herbion Pakistan (Pvt.) Ltd (645482936)

Registrant - Herbion Pakistan (Pvt.) Ltd (645482936)

Establishment
Name	Address	ID/FEI	Business Operations
Herbion Pakistan (Pvt.) Ltd		645482936	manufacture(44237-043)