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Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Bronchitis Common Cold 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


IMPRINT: FR12     SHAPE: round
    COLOR: white

All Imprints

acetaminophen 325 mg / dextromethorphan hydrobromide 15 mg / guaifenesin 200 mg / phenylephrine hydrochloride 5 mg oral tablet - fr12 round white

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Drug Facts

Otc - Active Ingredient Section


OTC - PURPOSE SECTION

Active ingredients (in each tablet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant

Uses

  • for the temporary relief of the following cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
    • impulse to cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

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.

Sore throat warning


If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

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.

OTC - ASK DOCTOR SECTION


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

OTC - ASK DOCTOR/PHARMACIST SECTION


Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin

OTC - WHEN USING SECTION


When using this product
  • do not exceed recommended dosage

OTC - STOP USE SECTION


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 2 tablets with water every 6-8 hours as needed
  • do not take more than 8 tablets in 24 hours, or as directed by a doctor
children under 12 years of age
  • ask a doctor

Other Information

  • do not use if carton or inner pouch is open or torn
  • store at room temperature 59-86° F (15-30° C)
  • avoid excessive heat and humidity
  • see bottom panel or pouch for expiration date and lot number

Inactive Ingredients


maltodextrin, microcrystalline cellulose, povidone, 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 - 6 Tablet Pouch Carton


QUALITY GUARANTEED

on the Go PACKS Cold

Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl Pain Reliever/Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant

Non-Drowsy Relief of
  • Cough, Impulse to Cough
  • Nasal Congestion
  • Sore Throat

SEVERE CONGESTION

6 Tablets 3 POUCHES, 2 TABLETS PER POUCH

Lil' DrugStore ®



Principal Display Panel - 20 Tablet Carton - 9828


EZ Paks â„¢ Stores & Travels Easily!

Compare to the active ingredients in Tylenol ® Cold Head Congestion*

NON-DROWSY FORMULA

Cold Relief Pain Reliever/Fever Reducer, Expectorant, Nasal Decongestant, Cough Suppressant

SEVERE CONGESTION

Contains 4 Active Medicines: Acetaminophen... relieves Headache, Sore Throat

Dextromethorphan HBr...relieves Coughing

Guaifenesin...relieves Chest Congestion

Phenylephrine HCl...relieves Nasal Congestion

20 TABLETS IN 10 POUCHES OF 2 TABLETS

Lil' Drug Store ®



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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