Guaifenesin and Pseudoephedrine HCl
Tablet, Extended Release · Oral
Active ingredient
Active ingredients (in each extended-release tablet) (For 600 mg/60 mg) Guaifenesin USP, 600 mg Pseudoephedrine HCL USP, 60 mg (For 1200 mg/120 mg) Guaifenesin USP, 1200 mg Pseudoephedrine HCL USP, 120 mg
Purpose
Purposes Expectorant Nasal Decongestant
Uses
Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome 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
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 you have
• 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 a 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Centre right away (1-800 222-1222). Other information
• Tamper evident: do not use if carton is open or if printed seal on blister is broken or missing.
• store between 20-25°C (68-77°F)
Ask a doctor before use
Ask a doctor before use if you have
• 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
When using this product
• do not use more than directed
Stop use and ask a doctor
Stop use and ask a 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 or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Centre right away (1-800 222-1222).
Directions
Directions
• do not crush, chew, or break extended-release tablet
• take with a full glass of water
• this product can be administered without regard for timing of meals
• adults and children 12 years and older: For 600 mg/60 mg: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours For 1200 mg/120 mg: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
• children under 12 years of age: do not use
Inactive ingredients
Inactive ingredients carbomer homopolymer Type B, cellulose microcrystalline, hypromellose, lake of FD&C yellow 6, magnesium stearate, sodium starch glycolate Type A
Questions?
Questions or comments? Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST. You may also report side effects to this phone number. Keep the carton. It contains important information. See end panel for expiration date. Manufactured By: Granules India Limited Hyderabad – 500 081, INDIA MADE IN INDIA Distributed By: Granules USA, Inc. Parsippany, NJ 07054
Label text from the FDA structured product label by Granules India Ltd (revised Dec 2, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Guaifenesin in 16 products
- Pseudoephedrine Hydrochloride in 16 products
Guaifenesin and Pseudoephedrine HCl NDC products (16)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 46122-801 | Guaifenesin 600 mg/1; Pseudoephedrine Hydrochloride 60 mg/1 Tablet, Extended Release | Amerisource Bergen | ANDA |
| 58602-833 | Guaifenesin 600 mg/1; Pseudoephedrine Hydrochloride 60 mg/1 Tablet, Extended Release | Aurohealth LLC | ANDA |
| 58602-834 | Guaifenesin 1200 mg/1; Pseudoephedrine Hydrochloride 120 mg/1 Tablet, Extended Release | Aurohealth LLC | ANDA |
| 55111-798 | Guaifenesin 600 mg/1; Pseudoephedrine Hydrochloride 60 mg/1 Tablet, Extended Release | Dr. Reddys Laboratories Limited | ANDA |
| 55111-799 | Guaifenesin 1200 mg/1; Pseudoephedrine Hydrochloride 120 mg/1 Tablet, Extended Release | Dr. Reddys Laboratories Limited | ANDA |
| 62207-827 | Guaifenesin 600 mg/1; Pseudoephedrine Hydrochloride 60 mg/1 Tablet, Extended Release | Granules India Ltd | ANDA |
| 62207-828 | Guaifenesin 1200 mg/1; Pseudoephedrine Hydrochloride 120 mg/1 Tablet, Extended Release | Granules India Ltd | ANDA |
| 30142-137 | Guaifenesin 600 mg/1; Pseudoephedrine Hydrochloride 60 mg/1 Tablet, Extended Release | KROGER COMPANY | ANDA |
| 79481-1002 | Guaifenesin 600 mg/1; Pseudoephedrine Hydrochloride 60 mg/1 Tablet, Extended Release | Meijer | ANDA |
| 51660-074 | Guaifenesin 600 mg/1; Pseudoephedrine Hydrochloride 60 mg/1 Tablet, Extended Release | Ohm Laboratories, Inc. | ANDA |
| 51660-077 | Guaifenesin 1200 mg/1; Pseudoephedrine Hydrochloride 120 mg/1 Tablet, Extended Release | Ohm Laboratories, Inc. | ANDA |
| 11822-0046 | Guaifenesin 600 mg/1; Pseudoephedrine Hydrochloride 60 mg/1 Tablet, Extended Release | Rite Aid Corporation | ANDA |
| 70677-1263 | Guaifenesin 600 mg/1; Pseudoephedrine Hydrochloride 60 mg/1 Tablet, Extended Release | Strategic Sourcing Services LLC | ANDA |
| 70677-1011 | Guaifenesin 600 mg/1; Pseudoephedrine Hydrochloride 60 mg/1 Tablet, Extended Release | Strategic Sourcing Services, LLC | ANDA |
| 0363-0134 | Guaifenesin 1200 mg/1; Pseudoephedrine Hydrochloride 120 mg/1 Tablet, Extended Release | WALGREEN CO. | ANDA |
| 0363-9946 | Guaifenesin 600 mg/1; Pseudoephedrine Hydrochloride 60 mg/1 Tablet, Extended Release | WALGREEN CO. | ANDA |
Frequently asked questions
What is Guaifenesin and Pseudoephedrine HCl used for?
Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome 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…
Who makes Guaifenesin and Pseudoephedrine HCl?
Guaifenesin and Pseudoephedrine HCl is listed by 11 labelers in the FDA NDC directory, including Amerisource Bergen, Aurohealth LLC, Dr. Reddys Laboratories Limited, Granules India Ltd.