Label: GUAIATUSSIN AC- codeine phosphate and guaifenesin liquid 

  • Label RSS
  • NDC Code(s): 50383-087-04, 50383-087-05, 50383-087-07, 50383-087-10, view more
    50383-087-12, 50383-087-16
  • Packager: Hi-Tech Pharmacal Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/13

If you are a consumer or patient please visit this version.

  • Active ingredients (in each 5mL teaspoonful)

    Codeine Phosphate, USP 10 mg

    Guaifenesin, USP 100 mg

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  • Purposes

    Cough Suppressant

    Expectorant

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  • Use

    • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
    • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
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  • Warnings

    Do not use

    • in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.

    Ask a doctor before use if you have

    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before use if you are

    taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

    Stop use and ask a doctor if

    • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.
    • may cause or aggravate constipation

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

    • Use of codeine-containing preparation is not recommended for children under 2 years of age
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  • Directions

    • take every 4 hours
    • do not exceed 6 doses in 24 hours
    • a special measuring device should be used to give an accurate dose of this product to children under 6 years of age
    • giving a higher dose than recommended by a doctor can result in serious side effects for a child
    adults and children 12 years and over 2 teaspoonfuls
    children 6 to under 12 years of age 1 teaspoonful
    children under 6 years of age Consult a doctor
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  • Other information

    • each (5 mL) teaspoon contains: 1 mg sodium
    • Tamper evident: Do not use if seal under cap is broken or missing
    • Keep container closed and store away from heat
    • Store at room temperature 15°-30°C (59°-86°F)
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  • Inactive ingredients

    alcohol 3.5% v/v, artificial cherry flavor, caramel, citric acid, FD&C red # 40, glycerin, polyethylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution.

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  • Questions or comments?

    Call 1-800-262-9010, Mon. - Thurs. 9:00 am thru 4:30 pm EST, Fri. 9:00 am thru 2:30 pm EST.

    Serious side effects associated with use of this product may be reported to this number.

    REV. 087:01 9/11

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  • Package/Label Principal Display Panel

    Image of Container Label

    NDC 50383-087-16

    Guaiatussin AC

    Sugar-Free

    CV

    • Expectorant
    • Cough Suppressant

    Each teaspoonful (5 mL) contains

    Guaifenesin...............................100 mg

    Codeine Phosphate..................10 mg

    Alcohol.......................................3.5 % v/v

    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701

    16 fl oz (473 mL)

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  • INGREDIENTS AND APPEARANCE
    GUAIATUSSIN AC 
    guaifenesin and codeine phosphate liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50383-087
    Route of Administration ORAL DEA Schedule CV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 10 mg  in 5 mL
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    CARAMEL  
    ANHYDROUS CITRIC ACID  
    FD&C RED NO. 40  
    GLYCERIN  
    POLYETHYLENE GLYCOL 4000  
    WATER  
    SACCHARIN SODIUM  
    SODIUM BENZOATE  
    SORBITOL  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (artificial cherry flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50383-087-16 473 mL in 1 BOTTLE
    2 NDC:50383-087-04 118 mL in 1 BOTTLE
    3 NDC:50383-087-07 10 in 1 CASE
    3 10 in 1 TRAY
    3 NDC:50383-087-05 5 mL in 1 CUP, UNIT-DOSE
    4 NDC:50383-087-12 10 in 1 CASE
    4 10 in 1 TRAY
    4 NDC:50383-087-10 10 mL in 1 CUP, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/08/2010
    Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    Name Address ID/FEI Business Operations
    Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE(50383-087)
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