Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 51ec068b-e219-381a-384b-a208a306d5ba
Route
ORAL
Published
Effective Date 2017-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg) Pseudoephedrine (60 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Hypromelloses Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Povidone Silicon Dioxide

Identifiers & Packaging

Marketing Status
ANDA Active Since 2020-07-27

Description

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


Medication Information

Purpose

Expectorant and Nasal Decongestant

Description

Guaifenesin USP, 600 mg................................................................................Expectorant Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant   Guaifenesin USP, 1200 mg................................................................................Expectorant Pseudoephedrine HCl USP, 120 mg......................................................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 

Storage

■ store between 20°-25°C (68°-77°F)

Warnings

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

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 

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.

Other Information

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

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 

Inactive Ingredients

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

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

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

When Using This Product

■ do not use more than directed 

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) 

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.

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).


Structured Label Content

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 

Purpose

Expectorant and Nasal Decongestant

Storage

■ store between 20°-25°C (68°-77°F)

Warnings

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

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 

Do Not Use (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.

Other Information (Other information)

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

Active Ingredient(s) (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 

Inactive Ingredients (Inactive ingredients)

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

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel

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

When Using This Product (When using this product)

■ do not use more than directed 

Ask A Doctor Before Use If (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) 

Stop Use and Ask Doctor If (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.

Keep Out of Reach of Children (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).


Advanced Ingredient Data


Raw Label Data

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