Guaifenesin and Pseudoephedrine Hydrochloride
Tablet, Extended Release · Oral
Active ingredient
Active ingredients (in each extended-release tablet) Purposes Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 mg Nasal Decongestant
Purpose
Active ingredients (in each extended-release tablet) Purposes Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 mg 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 Center right away (1-800-222-1222).
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.
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 Center right away (1-800-222-1222).
Directions
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
• adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
• children under 12 years of age: do not use
Other information
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)
Inactive ingredients
Inactive ingredients carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF
Questions?
Questions? (1-800-406-7984) You may also report side effects to this phone number.
Label text from the FDA structured product label by WALGREEN COMPANY (revised Oct 27, 2018). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Guaifenesin in 3 products
- Pseudoephedrine Hydrochloride in 3 products
Guaifenesin and Pseudoephedrine Hydrochloride NDC products (3)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 41415-994 | Guaifenesin 600 mg/1; Pseudoephedrine Hydrochloride 60 mg/1 Tablet, Extended Release | PUBLIX SUPER MARKETS, INC | ANDA |
| 62011-0475 | Guaifenesin 600 mg/1; Pseudoephedrine Hydrochloride 60 mg/1 Tablet, Extended Release | STRATEGIC SOURCING SERVICES LLC | ANDA |
| 0363-0077 | Guaifenesin 600 mg/1; Pseudoephedrine Hydrochloride 60 mg/1 Tablet, Extended Release | WALGREEN COMPANY | NDA |
Frequently asked questions
What is Guaifenesin and Pseudoephedrine Hydrochloride 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 Hydrochloride?
Guaifenesin and Pseudoephedrine Hydrochloride is listed by 3 labelers in the FDA NDC directory, including PUBLIX SUPER MARKETS, INC, STRATEGIC SOURCING SERVICES LLC, WALGREEN COMPANY.