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Generic: acetaminophen, guaifenesin, and phenylephrine hydrochloride is used for the treatment of Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Bronchitis Common Cold Cough Laryngitis Pharyngitis Rhinitis, Allergic, Perennial Sinusitis Whooping Cough Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular


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Drug Facts

Otc - Active Ingredient Section


OTC - PURPOSE SECTION

Active ingredients (in each tablet) Purpose
Acetaminophen 325 mg Pain reliever
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant

Uses

  • For the temporary relief of:
    • sinus congestion and pressure
    • nasal congestion
    • headache
    • minor aches and pains
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves nasal congestion due to the common cold, hay fever and other upper respiratory allergies

Warnings


Liver warning


This product contains acetaminophen. Severe liver damage may occur if you take:
  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product.

Allergy alert


Acetaminophen may cause severe skin reactions. Symptoms may include:
  • skin reddening
  • bulers
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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

  • liver disease
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage

Stop use and ask a doctor if

  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or is accompanied by a fever, rash or persistent headache
  • nervousness, dizziness or sleeplessness occur.

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION


If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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)

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

adults and children 12 years and over
  • take 1-2 tablets every 4 hours as needed
  • do not take more than 12 tablets in 24 hours, or as directed by a doctor
children under 12 years of age
  • consult a doctor

Other Information

  • store at room temperature 59-86°F (15-30°C)
  • avoid excessive heat and humidity

Inactive Ingredients


FD&C red #40, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide may contain, sodium starch glycolate, starch, stearic acid

Questions Or Comments?


call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Principal Display Panel - 16 Tablet Pouch Carton


QUALITY GUARANTEED

Compare to the Active Ingredients in Tylenol® Sinus Severe †

Sinus Relief

on the Go PACKS

Multi-Symptom Sinus

Acetaminophen, Guaifenesin, Phenylephrine HCl Pain Reliever, Expectorant, Nasal Decongestant

Non-Drowsy Relief of
  • Chest Congestion
  • Nasal Congestion
  • Sinus Pressure

SEVERE CONGESTION

16 Tablets 8 POUCHES, 2 TABLETS PER POUCH

Lil' DrugStore ®

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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