Label: ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated

  • NDC Code(s): 57344-124-02, 57344-124-03
  • Packager: AAA Pharmaceutical, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 31, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each caplet) Purpose
    Acetaminophen 325 mg Pain reliever/fever reducer
    Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant
    Phenylephrine HCl 5 mg Nasal decongestant
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  • Uses

    • temporarily relieves these symptoms of the common cold:
      • runny nose
      • sneezing
      • headache
      • sore throat
      • minor aches and pains
      • nasal congestion
      • cough
    • temporarily reduces fever
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  • Warnings

    Liver warning

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

    • more than 12 caplets in 24 hours, 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

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • with any other product containing diphenhydramine, even one used on skin
    • 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.

    Ask a doctor before use if you have

    • liver disease
    • diabetes
    • heart disease
    • high blood pressure
    • thyroid disease
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by too much phlegm (mucus)
    • a breathing problem such as emphysema or chronic bronchitis

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

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • 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
    • 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 (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    adults and children 12 years and over
    • take 2 caplets every 4 hours
    • do not to take more than 12 caplets in 24 hours
    children under 12 years
    • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
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  • Other information

    • store between 20°-25°C (68°-77°F) in a dry place
    • retain carton for complete product information
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  • Inactive ingredients

    colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose anhydrous, magnesium stearate, methylparaben, polyethylene glycol, povidone, pregelatinized starch, propylparaben, sodium starch glycolate, stearic acid, titanium dioxide

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048

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  • PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

    RESTORE u

    NDC 57344-124-03

    COMPARE TO THE ACTIVE
    INGREDIENTS IN SUDAFED PE ®
    SEVERE COLD

    Severe Cold PE
    For Adults

    Acetaminophen, Diphenhydramine HCI, Phenylephrine HCl
    Pain Reliever-Fever Reducer, Antihistamine/Cough Suppressant, Nasal Decongestant

    Relieves:

    • Sore Throat, Head & Body Aches
    • Cough, Runny Nose & Sneezing
    • Sinus Pressure & Congestion

    24 CAPLETS

    Principal Display Panel - 24 Caplet Blister Pack Carton
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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE 
    acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-124
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white Score no score
    Shape OVAL Size 17mm
    Flavor Imprint Code AAA;1115
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-124-02 1 in 1 CARTON 12/22/2012
    1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:57344-124-03 2 in 1 CARTON 12/22/2012
    2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 12/22/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
    Establishment
    Name Address ID/FEI Business Operations
    AAA Pharmaceutical, Inc. 080164679 manufacture(57344-124)
    Establishment
    Name Address ID/FEI Business Operations
    AAA Pharmaceutical, Inc. 181192162 pack(57344-124)
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