Label: LITTLE REMEDIES NEW BABY ESSENTIALS- acetaminophen, simethicone, zinc oxide kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 11, 2019

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  • SPL UNCLASSIFIED SECTION

    FOR FEVERSTM

    INFANT FEVER + PAIN RELIEVER  Acetaminophen

    Drug Facts                                          

  • Active ingredient

    (in each 5 mL)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever / Fever reducer

  • Uses

    Temporarily:

    • reduces fever
    • relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.
  • 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 acetaminophen.

    Sore Throat Warning: If sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

    Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ▪ skin reddening ▪ blisters ▪ rash. If a skin reaction occurs, stop use and seek medical help right away.

    Do not use

    • with any other products containing acetaminophen (prescription or non-prescription).

          If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

    Ask a doctor before use if the child has

    liver disease.

    Ask a doctor or pharmacist before use if the child is

    taking the blood thinning drug warfarin.

    When using this product

    do not exceed recommended dose (see overdose warning)

    Stop use and ask a doctor if

    • new symptoms occur
    • fever gets worse or lasts more than 3 days
    • pain gets worse or lasts more than 5 days
    • redness or swelling is present. These could be signs of a serious condition.

    Keep out of reach of children.

    Overdose Warning: Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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.

    • Shake well before using
    • Find the right dose on the chart on the chart below. If possible, use weight to determine dose; otherwise, use age.
    • Only use the enclosed AccuSafe® syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.  
    • Remove cap, insert syringe to flow restrictor and invert bottle
    • Pull back syringe until filled to the prescribed level and slowly dispense the liquid into your child’s mouth (towards the inner cheek)
    • If needed, repeat dose every 4 hours while symptoms last
    • Do not give more than 5 times in any 24-hour period (see overdose warning)
    • Do not give more than 5 days unless directed by a doctor
    • Replace cap tightly to maintain child resistance

    mL = milliliter

    Weight (lbs)Age (yrs)Dose (mL)
    Under 24under 2Ask a doctor
    24-352-35 mL
  • Other information

    • Store at 20°-25°C (68°-77°F)  
    • AccuSafe® Oral dosing device enclosed
    • Check expiration date on bottle or box before using.
  • Inactive ingredients

    benzoic acid, carboxymethylcellulose, glycerin, natural grape flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, xanthan gum

    FOR DIAPER RASH
    BOUDREAUX’S BUTT PASTE ® Diaper Rash Ointment

    Drug Facts
    Active ingredient Purpose
    Zinc oxide, 16%...................................................Skin protectant
    Uses
    • Helps treat and prevent diaper rash
    • Protects chafed skin due to diaper rash and helps seal out wetness
    Warnings
    For external use only
    When using this product avoid contact with the eyes
    Stop use and ask a doctor if condition worsens or does not improve after 7 days
    Keep out of the reach of children to prevent accidental ingestion
    If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately
    Directions
    • Change wet and soiled diaper immediately
    • Cleanse the diaper area and allow to dry
    • Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime
    Other information
    • Store at room temperature 20°- 27°C (68°- 80°F)
    • Remove seal from jar before use
    • Use with infants, children and adults
    • Will stain clothing and fabric
    Inactive ingredients castor oil, mineral oil, paraffin, peruvian balsam, white petrolatum
    Questions?
    1-855-785-2888 www.buttpaste.com

    FOR TUMMYSTM

    GAS RELIEF DROPS Simethicone / Antigas

    Drug Facts

  • Active ingredient (in each 0.3 mL)

    Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg

  • Purpose

    Antigas

  • Uses

    Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food

  • Warnings

    Keep out of reach of children.

  • Directions

    ■ shake well before using

    ■ only use enclosed syringe; fill to prescribed level and dispense liquid slowly into child’s mouth, toward inner cheek

    ■ all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day.

    ■ dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids

    ■ for best results, clean syringe after each use and replace original cap

    If possible, use weight to determine dose; otherwise use age.

    mL = milliliters

    Age (yrs)Weight (lbs)Dose
    Newborns &
    Infants under 2 years
    under 240.3 mL
    Children 2 years and over24 and over0.6 mL
  • Other information

    ■ do not freeze ■ store at room temperature 20˚-25˚C (68˚-77˚F)

    ■ See bottle or box for lot number and expiration date

  • Inactive ingredients

    carmellose sodium,citric acid, microcrystalline cellulose, natural strawberry flavor, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum

    FOR TUMMYSTM

    GRIPE WATER

    Supplement Facts
    Serving Size: 5 mL
    Servings per Container: about 12
    Amount per Serving% Daily Value
    Zingiber officinale (Ginger) Root Extract       5 mg      
    Foeniculum vulgare (Fennel) Seed Extract       4mg
    †Daily Value not established
  • Other ingredients

    purified water, agave, glycerin, natural ginger flavor, potassium sorbate, citric acid, xanthan gum

    Suggested Use
    AgeDose
    2 to 4 weeks2.5 mL
    1 to 6 months5 mL
    6 months and older10 mL
    Adults30 mL

    SHAKE WELL. May be taken directly using the dispenser included. May be given up to six times in a 24 hour period. If necessary to repeat dosage, wait a minimum of 30 minutes. Do not use if safety seal is broken or missing.

    Keep out of reach of children.

    In some infants, a rare allergic reaction may occur. Do not exceed recommended dosage.

    Do not use if

    ▪ child has a history of kidney failure or renal problems ▪ child is allergic to any of the ingredients in this product Always consult your health care provider before giving this or any supplement to an infant. ▪ Store at room temperature.

    FOR NOSESTM

    SALINE SPRAY + DROPS 

  • Uses

    –Helps loosen mucus secretions to aid aspiration and removal from nose and sinuses, allowing for easier breathing. For infants this can be assisted with the use of our specially designed “Soft Tip” Nasal Aspirator.

  • Warnings

    Keep out of reach of children.

    ▪ The use of this dispenser by more than one person may spread infection.

    ▪ Wipe nozzle clean after each use.

  • Directions

    (For nasal use only)

    ▪ Infants: 2 to 6 drops in each nostril as often as needed or as directed by your doctor. 

    ▪Children: 2 to 6 sprays or drops into each nostril as often as needed or as directed by a doctor.

    Store at 20°-25°C (68°-77°F).

    See bottle for lot and expiration date.

  • Ingredients:

    water, sodium chloride, glycerin, sodium benzoate, benzoic acid

  • PRINCIPAL DISPLAY PANEL

    Little Remedies®

    New Baby Essentials Kit

    INFANT FEVER/PAIN RELIEVER

    ACETAMINOPHEN / FEVER/PAIN RELIEVER

    2 FL OZ (59 mL)

    Syringe Included

    GAS DROPS

    SIMETHICONE /ANTIGAS

    1 FL OZ (30 mL)

    Syringe Included

    DIAPER RASH OINTMENT

    ZINC OXIDE / SKIN PROTECTANT

    2 OZ (57 g)

    SALINE SPRAY + DROPS

    0.5 FL OZ (15 mL)

    GRIPE WATER

    GINGER / FENNEL SUPPLEMENT

    2 FL OZ (59 mL)

    Syringe Included

    Nasal Aspirator

    PRINCIPAL DISPLAY PANEL

Little Remedies®
New Baby Essentials Kit

INFANT FEVER/PAIN RELIEVER 
ACETAMINOPHEN / FEVER/PAIN RELIEVER 
2 FL OZ (59 mL)
Syringe Included

GAS DROPS
SIMETHICONE /ANTIGAS
1 FL OZ (30 mL)
Syringe Included

DIAPER RASH OINTMENT 
ZINC OXIDE / SKIN PROTECTANT  
2 OZ (57 g) 

SALINE SPRAY + DROPS 
0.5 FL OZ (15 mL)

GRIPE WATER 
GINGER / FENNEL SUPPLEMENT
2 FL OZ (59 mL)
Syringe Included

Nasal Aspirator

  • INGREDIENTS AND APPEARANCE
    LITTLE REMEDIES NEW BABY ESSENTIALS 
    acetaminophen, simethicone, zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-615
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-615-011 in 1 CARTON; Type 0: Not a Combination Product02/15/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 59 mL
    Part 21 BOTTLE 30 mL
    Part 31 TUBE 57 g
    Part 41 BOTTLE 59 mL
    Part 51 BOTTLE 15 mL
    Part 1 of 5
    LITTLE REMEDIES INFANT FEVER AND PAIN RELIEVER 
    acetaminophen liquid
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34302/15/2017
    Part 2 of 5
    LITTLE REMEDIES RELIEF 
    simethicone liquid
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33202/15/2017
    Part 3 of 5
    BOUDREAUXS 
    zinc oxide cream
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    BALSAM PERU (UNII: 8P5F881OCY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorWHITE (Beige) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34702/15/2017
    Part 4 of 5
    GRIPE WATER 
    ginger and fennel liquid
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER5 mg  in 5 mL
    FENNEL (UNII: 557II4LLC3) (FENNEL - UNII:557II4LLC3) FENNEL4 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT02/15/2017
    Part 5 of 5
    SALINE 
    other baby products spray
    Product Information
    Route of AdministrationNASAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    INGRPOTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
    INGRBENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    ColorWHITE (clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC02/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/15/2017
    Labeler - Medtech Products Inc. (122715688)