ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH]

ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH]
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NDC 0031-8721-02, 0031-8721-20
Set ID 21d99875-3571-4f27-a97b-bccd76ec3dd5
Category HUMAN OTC DRUG LABEL
Packager Richmond Division of Wyeth
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each liquid-filled capsule)Purposes
    Acetaminophen, USP 325 mgPain reliever/Fever reducer
    Dextromethorphan HBr, USP 10 mgCough suppressant
    Phenylephrine HCl, USP 5 mgNasal decongestant
  • Uses

    • temporarily relieves these symptoms occurring with a cold or flu:
      • headache
      • nasal congestion
      • sore throat
      • cough
      • minor aches and pains
    • temporarily reduces fever
  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 12 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

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

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking any other oral nasal decongestant or stimulant
    • taking any other pain reliever/fever reducer

    When using this product do not use more than directed

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • pain, cough, or nasal congestion 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

    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. 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 12 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
    agedose
    adults and children 12 years and over2 capsules every 4 hours
    children under 12 yearsdo not use
  • Other information

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

    FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mineral oil, 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

  • SPL UNCLASSIFIED SECTION

    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

    ADULT

    Robitussin®

    PEAK COLD

    DAYTIME

    Cold + Flu

    ACETAMINOPHEN (Pain Reliever / Fever Reducer)
    DEXTROMETHORPHAN HBr (Cough Suppressant)
    PHENYLEPHRINE HCl (Nasal Decongestant)

    Relieves:

    Cough
    Body Ache
    Fever
    Sore Throat
    Nasal Congestion

    Non-Drowsy

    For Ages 12 & Over

    20
    LIQUID-FILLED
    CAPSULES

    Principal Display Panel - 20 Capsule Carton
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8721
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K12 (UNII: 333AG72FWJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    ColorORANGE (clear orange) Scoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8721-2020 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0031-8721-0230 in 1 CARTON
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34104/15/2012
    Labeler - Richmond Division of Wyeth (829390835)

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