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Safeway Nighttime Cold and Flu (Safeway, Inc.)

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Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 1 BLISTER PACK in 1 BOX (21130-480-24) > 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK Label Information

Complete Safeway Nighttime Cold and Flu Information

  • Active Ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan Hydrobromide 15 mg

    Doxylamine Succinate 6.25 mg

    Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistimine


  • Uses

    • temporarily relieves common cold and flu symptoms:
      • sore throat
      • headache
      • minor aches and pains
      • fever
      • runny nose and sneezing
      • cough due to minor throat and bronchial irritation

  • 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
    • to make a child sleep
    • 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 of pharmacist before taking this product.

    Ask a doctor before use if you have
    • liver disease
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough that such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)

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

    When using this product
    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • avoid alcoholic drinks
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    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
    • new symptoms occur
    • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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 directed (see Overdose warning)
    • do not take more than 4 doses in 24 hours
    • adults and children 12 years and over: take 2 softgels with water every 6 hours
    • swallow whole; do not crush, chew, or dissolve
    • children under 12 years: do not use
    • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

  • Other Information

    • store at room temperature 15º-30ºC (59º-86ºF)
    • avoid excessive heat

  • Inactive Ingredients

    D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol


  • Questions or Comments?

    Call 1-888-723-3929 Monday-Friday 7AM-6PM PST


  • Principal Display Panel

    Compare to Vicks® NyQuil® LiquiCaps® active ingredients*

    Nighttime Cold & Flu

    Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

    Multi-Symptom

    Pain Reliever  Fever Reducer

    Cough Suppressant   Antihistamine

    SOFTGELS

    DISTRIBUTED BY SAFEWAY INC., P.O. BOX 99

    PLEASANTON, CA 94566-0009

    1-888-SAFEWAY / www.safeway.com

    *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil® LiquiCaps®.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.


  • Package Label

    Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Doxylamine Succinate 6.25 mg

    Safeway Nighttime Cold & Flu Softgel


  • INGREDIENTS AND APPEARANCE
    SAFEWAY NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-480
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color GREEN (GREEN) Score no score
    Shape OVAL (OVAL) Size 21mm
    Flavor Imprint Code P30;94A;35A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-480-24 1 in 1 BOX
    1 24 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 11/29/2012
    Labeler - Safeway, Inc. (009137209)