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ROBITUSSIN PEAK COLD NIGHTTIME COLD PLUS FLU (acetaminophen 325 mg dextromethorphan hydrobromide 15 mg doxylamine succinate 6.25 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. Richmond Division of Wyeth

Generic: acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate

ROBITUSSIN PEAK COLD NIGHTTIME COLD PLUS FLU solution - (acetaminophen 325 mg dextromethorphan hydrobromide 15 mg doxylamine succinate 6.25 mg) image

IMPRINT: R     SHAPE: capsule
    COLOR: green

  1. FDA Adverse Reactions

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Drug Facts

Otc - Active Ingredient Section


OTC - PURPOSE SECTION

Active ingredients (in each liquid-filled capsule) Purposes
Acetaminophen, USP 325 mg Pain reliever/Fever reducer
Dextromethorphan HBr, USP 15 mg Cough suppressant
Doxylamine Succinate, USP 6.25 mg Antihistamine

Uses

  • temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies:
    • headache
    • sore throat
    • cough
    • minor aches and pains
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily reduces fever

Warnings


Liver warning


This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 8 capsules in any 24-hour period, which is the maximum daily amount
  • 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

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

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or 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
  • taking any other pain reliever/fever reducer
  • taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition.
  • new symptoms occur

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

Directions

  • do not take more than 8 capsules in any 24-hour period
  • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • this adult product is not intended for use in children under 12 years of age
age dose
adults and children 12 years and over 2 capsules every 6 hours
children under 12 years do not use

Other Information

  • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).

Inactive Ingredients


D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments?


Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675


Distributed by: Pfizer, Madison, NJ 07940 USA

Made in Canada

For most recent product information, visit www.robitussin.com

Principal Display Panel - 20 Capsule Carton


NEW!ADULT

Robitussin®

PEAK COLD

NIGHTTIME

Cold+Flu

ACETAMINOPHEN (Pain Reliever / Fever Reducer)DEXTROMETHORPHAN HBr (Cough Suppressant)DOXYLAMINE SUCCINATE (Antihistamine)

Relieves:
  • ✔Cough
  • ✔Body Ache
  • ✔Sore Throat & Fever
  • ✔Runny Nose
  • ✔Sneezing

For Ages 12 & Over

20 LIQUID-FILLEDCAPSULES

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."

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"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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