Label: LITTLE REMEDIES NEW BABY ESSENTIALS- acetaminophen, simethicone, zinc oxide kit
- NDC Code(s): 63029-615-01
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated March 11, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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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.
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.
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Directions
This product does not contain directions or complete warnings for adult use.
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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 24 under 2 Ask a doctor 24-35 2-3 5 mL -
Shake well before using
- Other information
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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 OintmentDrug 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)
- Purpose
- Uses
- Warnings
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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 yearsunder 24 0.3 mL Children 2 years and over 24 and over 0.6 mL - Other information
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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 12Amount 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 Age Dose 2 to 4 weeks 2.5 mL 1 to 6 months 5 mL 6 months and older 10 mL Adults 30 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.
- Uses
- Warnings
- Directions
- Ingredients:
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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
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INGREDIENTS AND APPEARANCE
LITTLE REMEDIES NEW BABY ESSENTIALS
acetaminophen, simethicone, zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-615 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-615-01 1 in 1 CARTON; Type 0: Not a Combination Product 02/15/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 59 mL Part 2 1 BOTTLE 30 mL Part 3 1 TUBE 57 g Part 4 1 BOTTLE 59 mL Part 5 1 BOTTLE 15 mL Part 1 of 5 LITTLE REMEDIES INFANT FEVER AND PAIN RELIEVER
acetaminophen liquidProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 59 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 02/15/2017 Part 2 of 5 LITTLE REMEDIES RELIEF
simethicone liquidProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 20 mg in 0.3 mL Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part332 02/15/2017 Part 3 of 5 BOUDREAUXS
zinc oxide creamProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 16 g in 113 g Inactive Ingredients Ingredient Name Strength CASTOR OIL (UNII: D5340Y2I9G) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) BALSAM PERU (UNII: 8P5F881OCY) PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color WHITE (Beige) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 57 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 02/15/2017 Part 4 of 5 GRIPE WATER
ginger and fennel liquidProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 5 mg in 5 mL FENNEL (UNII: 557II4LLC3) (FENNEL - UNII:557II4LLC3) FENNEL 4 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Color WHITE (clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 59 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 02/15/2017 Part 5 of 5 SALINE
other baby products sprayProduct Information Route of Administration NASAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) INGR POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632) INGR BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) Product Characteristics Color WHITE (clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 02/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/15/2017 Labeler - Medtech Products Inc. (122715688)