ONLY FOR COUGH- guaifenesin, dextromethorphan hbr tablet

Only For by

Drug Labeling and Warnings

Only For by is a Otc medication manufactured, distributed, or labeled by O4 Global Trading Usa, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ONLY FOR  COUGH
guaifenesin, dextromethorphan hbr tablet

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/29/2019

Labeler - O4 Global Trading Usa, Llc (081226861)