Label: MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA- acetaminophen, dextromethorphan, phenylephrine hcl kit

  • NDC Code(s): 55319-933-22, 55319-934-08, 55319-935-02
  • Packager: FAMILY DOLLAR
  • Category: HUMAN OTC DRUG LABEL

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 February 26, 2021

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  • DRUG FACTS - DAY MAXIMUM STRENGTH COLD AND FLU (633T)

    DAY MAXIMUM STRENGTH COLD AND FLU

  • ACTIVE INGREDIENT

    Active ingredients (in each SOFTGEL)

    Acetaminophen 325 mg

    Dextromethorphan hydrobromide 10 mg

    Phenylephrine hydrochloride 5 mg

  • INACTIVE INGREDIENT

    Inactive ingredients: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

  • PURPOSE

    Purposes:

    • Pain reliever/fever reducer
    • Cough suppressant
    • Nasal decongestant
  • DOSAGE & ADMINISTRATION

    Directions

    · do not take more than the recommended dose

    · adults and children 12 years and over: take 2 capsules with water

    every 4 hours. Do not exceed 10 capsules in 24 hours or as

    directed by a doctor.

    · children under 12 years: do not use

  • INDICATIONS & USAGE

    Pain Reliever-Fever Reducer

    Cough Suppressant

    Antihistamine

    Nasal Decongestant

    • Nasal Congestion
    • Headache & Body Ache
    • Cough
    • Runny Nose
    • Sore Throat
  • WARNINGS

    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

    Allergy alert: Acetaminophen may cause severe skin or severe

    allergic reactions. Symptoms may include:

    · skin reddening · blisters · rash · hives

    · facial swelling · asthma (wheezing) · shock

    If a skin or general allergic reaction occurs, stop use and seek medical help right away.

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. 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.

  • DRUG FACTS - NIGHT MAXIMUM STRENGTH COLD AND FLU

    NIGHT MAXIMUM STRENGTH COLD AND FLU

  • ACTIVE INGREDIENT

    Active ingredeints in each softgel

    ACETAMINOPHEN 325 mg

    Dextromethorphan Hydrobromide 10 mg

    Doxylamine Succinate 6.25 mg

    Phenylephrine HCl 5 mg

  • INACTIVE INGREDIENT

    Inactive ingredients: FD&C Blue #1,gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, , sorbitol sorbitan solution, titanium dioxide

  • PURPOSE

    Pain Reliever-Fever Reducer

    Cough Suppressant

    Antihistamine

    /Nasal Decongestant

  • INDICATIONS & USAGE

    Uses

    · temporarily relieves these symptoms due to a cold or flu:

    · minor aches and pains · headache · cough

    · sore throat · nasal and sinus congestion

    · temporarily reduces fever

  • DOSAGE & ADMINISTRATION

    Directions

    · do not take more than the recommended dose

    · adults and children 12 years and over: take 2 capsules with water

    every 4 hours. Do not exceed 10 capsules in 24 hours or as

    directed by a doctor.

    · children under 12 years: do not use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. 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.

  • WARNINGS

    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 aloholic drinks every day while using this product

    l Allergy alert: Acetaminophen may cause severe skin or severe

    allergic reactions. Symptoms may include:

    · skin reddening · blisters · rash · hives

    · facial swelling · asthma (wheezing) · shock

    If a skin or general allergic reaction occurs, stop use and seek medical help right away.

    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.

  • PRINCIPAL DISPLAY PANEL

    20ct

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA 
    acetaminophen, dextromethorphan, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-935
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-935-021 in 1 BLISTER PACK; Type 0: Not a Combination Product08/02/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 12 
    Part 21 BLISTER PACK 8 
    Part 1 of 2
    MAXIMUM STRENGHT DAY COLD AND FLU FORMULA 
    acetaminophen, dextromethorphan, phenylephrine hcl capsule, liquid filled
    Product Information
    Item Code (Source)NDC:55319-933
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 70
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-933-2212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/20/2020
    Part 2 of 2
    MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled
    Product Information
    Item Code (Source)NDC:55319-934
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 72
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-934-088 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/02/2020
    Labeler - FAMILY DOLLAR (024472631)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LTD925822975manufacture(55319-935)
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