DRUG FACTS

Active ingredient (in each tablet)

Guaifenesin 400 mg

Dextromethorphan HBr 20mg

Purpose

Expectorant

Cough suppressant

Uses:

• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings:

Do not use

• 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.

• if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.

Stop use and consult a doctor

• if cough lasts more than 7 days, recurs or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Ask a doctor before use if you have

• persistent cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

• cough accompanied by too much phlegm (mucus)

When using this product

• do not exceed recommended dosage.

• do not use for more than 7 days

May cause or aggravate constipation.

If pregnant or breast-feeding,

ask a healthcare professional before use.

Keep out of reach of children. Overdose Warning

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

take with a full glass of water
do not take more than 6 tablets in 24 hours.


adults and children 12 years of age & over	1 tablet every 4 hrs
children under 12 years of age	Do not use

Other Information:

• Store at room temperature between 20-25°C (68-77°F).
• Store in a dry place
• Avoid excessive heat.

Inactive Ingredients:

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl povidone, sodium starch glyconate, stearic acid, talc

Questions Or Comments ?

1-833-665-9444.

NDC: 73006-101-41

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

Tear along perforation push product through foil

Packaging

image description

ONLY FOR COUGH
guaifenesin, dextromethorphan hbr tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73006-101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (Oblong)	Size	17mm
Flavor		Imprint Code	S55
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73006-101-41	1 in 1 CARTON	03/29/2019
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/29/2019

Labeler - O4 Global Trading Usa, Llc (081226861)

Only For - COUGH