GUAIFENESIN AND PSEUDOEPHEDRINE HCL tablet, extended release

Guaifenesin and Pseudoephedrine HCl by

Drug Labeling and Warnings

Guaifenesin and Pseudoephedrine HCl by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Guaifenesin USP, 600 mg................................................................................Expectorant

Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant 

Guaifenesin USP, 1200 mg................................................................................Expectorant

Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant 

Purpose

Expectorant and Nasal Decongestant

Use(s)

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive

■ temporarily relieves nasal congestion due to:

■ common cold

■ hay fever

■ upper respiratory allergies

■ temporarily restores freer breathing through the nose

■ promotes nasal and/or sinus drainage

■ temporarily relieves sinus congestion and pressure 

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.

Ask a doctor before use if

■ heart disease

■ high blood pressure

■ thyroid disease

■ diabetes

■ trouble urinating due to an enlarged prostate gland

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

■ cough accompanied by too much phlegm (mucus) 

When using this product

■ do not use more than directed 

Stop use and ask doctor if

■ you get nervous, dizzy, or sleepless

■ symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

■ do not crush, chew, or break tablet

■ take with a full glass of water

■ this product can be administered without regard for timing of meals

■ children under 12 years of age: do not use

■ adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours 

Other information

■ tamper evident: do not use if carton is open or if printed seal on blister is broken or missing.

Storage

■ store between 20°-25°C (68°-77°F)

Inactive ingredients

FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.

Questions

call 1-888-375-3784

You may also report side effect to this phone number.

Keep the carton.

It contains important information.

See end panel for expiration date.

Manufactured by:

Dr. Reddy’s Laboratories Limited

Srikakulam – 532 409 INDIA

Principal Display Panel

Guaifenesin and Pseudoephedrine HCl ER Tablets 600 mg/60 mg:

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
guaifenesin and pseudoephedrine hcl tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-0110(NDC:55111-798)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	600 mg
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	60 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	RDY;798
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-0110-1	1 in 1 CARTON	07/27/2020	04/30/2023
1		18 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
ANDA	ANDA208369	07/27/2020

Labeler - Strategic Sourcing Services, LLC (116956644)