Label: WELLY CHILDRENS TRAVEL MEDICINE- acetaminophen, calcium carbonate, diphenhydramine hydrochloride kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 15, 2020

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

  • Children's Pain and Fever Relief, 12 tablets

  • Drug Facts

  • Active ingredient (in each chewable tablet)

    Acetaminophen 160 mg

    Purpose

    Pain Reliever/ Fever Reducer

  • Uses

    • for the temporary relief of minor aches and pains associated with
    • the common cold
    • sore throat
    • headache
    • toothache
    • flu
    • and to reduce fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetominophen

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If skin 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.

    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.

    Ask a doctor before use if

    your child has liver disease.

    Ask a doctor or pharmacist before use if

    your child is taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    • pain persists for more than 5 days or gets worse
    • fever persists for more than 3 days or gets worse.
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition

    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 even if you do not notice any signs or symptoms.

  • Directions

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed
    • find the right dose on the chart below. If possible, use weight to dose; otherwise, use age.
    • chew or crush tablets completely before swallowing; do not swallow tablets whole
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    • do not give for more than 5 days unless directed by a doctor
     Weight (lb) Age (yr) Dose (chewable tablets)*
     Under 24 Under 2 Ask a doctor
     24-35 2-3 1 tablet
     36-47  4-5 1 1/2 tablets
     48-59  6-8  2 tablets
     60-71  9-10  2 1/2 tablets
     72-95  11  3 tablets

    *or as directed by a doctor

  • Other information

    TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • avoid high humidity
    • see label for expiration date and lot number
    • use by expiration date on package
  • Inactive ingredients

    citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

  • Questions or comments?

    1-833-BE-WELLY (1-833-239-3559)

  • Children's Stomach Soother, 12 tablets

  • Drug Facts

  • Active ingredient (in each tablet)

    Calcium carbonate 400 mg

    Purpose

    Antacid

  • Uses

    for the relief of

    • heartburn
    • sour stomach
    • acid indigestion
    • upset stomach associated with these symptoms
  • Warnings

    Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    • do not take more than 3 chewable tablets (ages 2-5) or 6 chewable tablets (ages 6-11) in a 24-hour period
    • do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor

  • Directions

    • find the right dose on the chart on the next page based on weight (preferred); otherwise use age
    • chew or crush tablets completely before swallowing; do not swallow tablets whole
    • repeat dose as needed, not more than 3 times a day
     Weight (lb) Age (yr) Dose (chewable tablets)*
     under 24 under 2 ask a doctor
     24-47 2-5 1 tablet
     48-95 6-11 2 tablets

    *or as directed by a doctor

  • Other information

    • Each chewable tablet contains: calcium 160 mg
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • avoid excessive humidity
    • see label for expiration date and lot number
    • use by expiration date on package
  • Inactive Ingredients

    acacia, cornstarch, D&C red# 27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, maltodextrin, silicon dioxide, sodium lauryl sulfate, sucrose, talc

  • Questions or comments?

    1-833-BE-WELLY (1-833-239-3559)

  • Children's Allergy Relief, 12 tablets

  • Drug Facts

  • Active ingredient (in each chewable tablet)

    Diphenhydramine HCI 12.5 mg

    Purpose

    Antihistamine

  • Use

    temporarily relieves runny nose and relieves sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • may cause excitability in children
    • may cause marked drowsiness; alcohol, sedatives, and traquilizers may increase the drowsiness effect
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery

    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.

  • Directions

    • find right dose on the chart below
    • chew or crush tablets completely before swallowing; do not swallow tablets whole
    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours
     Adults and children 12 years of age and over 2 to 4 chewable tablets (25 to 50 mg)
     Children 6 to under 12 years of age 1 to 2 chewable tablets (12.5 to 25 mg)
     Children under 6 years of age Consult a doctor

  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • avoid high humidity
    • see label for expiration date and lot number
    • use by expiration date on package
  • Inactive Ingredients

    D&C Red #27 Aluminum Lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C Blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

  • Questions or comments?

    1-833-BE-WELLY (1-833-239-3559)

  • Package Labeling:(72663-203-49)

    Kit

  • Package Labeling:(72663-233-49)

    Label

  • Package Labeling:(72663-225-49)

    Label2

  • Package Labeling:(72663-347-49)

    Label3

  • INGREDIENTS AND APPEARANCE
    WELLY CHILDRENS TRAVEL MEDICINE 
    acetaminophen, calcium carbonate, diphenhydramine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-203
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72663-203-491 in 1 KIT04/06/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BLISTER PACK 12 
    Part 22 BLISTER PACK 12 
    Part 32 BLISTER PACK 12 
    Part 1 of 3
    CHILDRENS PAIN AND FEVER RELIEF 
    acetaminophen tablet, chewable
    Product Information
    Item Code (Source)NDC:72663-233
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorpurpleScore2 pieces
    ShapeROUNDSize16mm
    FlavorImprint Code 44449
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72663-233-492 in 1 KIT
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/06/2020
    Part 2 of 3
    CHILDRENS STOMACH SOOTHER 
    calcium carbonate tablet, chewable
    Product Information
    Item Code (Source)NDC:72663-225
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION400 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize16mm
    FlavorImprint Code 44596
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72663-225-492 in 1 KIT
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/06/2020
    Part 3 of 3
    CHILDRENS ALLERGY RELIEF 
    diphenhydramine hydrochloride tablet, chewable
    Product Information
    Item Code (Source)NDC:72663-347
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code 44585
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72663-347-492 in 1 KIT
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/06/2020
    Labeler - Welly Health PBC (116766884)