Little Remedies New Baby Essentials Kit

Little Remedies New Baby Essentials Kit
SPL v2
SPL
SPL Set ID 4b1b7294-aca6-45fa-a008-c1869131b2a3
Routes
ORAL TOPICAL NASAL
Published
Effective Date 2024-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg) Dimethicone (20 mg) Zinc Oxide (16 g) Ginger (5 mg) Fennel (4 mg)
Inactive Ingredients
Benzoic Acid Carboxymethylcellulose Glycerin Microcrystalline Cellulose Sucrose Sodium Benzoate Water Xanthan Gum Carboxymethylcellulose Sodium Citric Acid Monohydrate Propylene Glycol Sucralose Castor Oil Mineral Oil Paraffin Balsam Peru Petrolatum Agave Tequilana Juice Potassium Sorbate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2017-02-15

Description

FOR FEVERS TM INFANT FEVER + PAIN RELIEVER    Acetaminophen Drug Facts                                          

Purpose

Pain reliever / Fever reducer


Medication Information

Purpose

Pain reliever / Fever reducer

Description

FOR FEVERS TM INFANT FEVER + PAIN RELIEVER    Acetaminophen Drug Facts                                          

Ing

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

Uses

Temporarily:

  • reduces fever

  • relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.
Section 42229-5

FOR FEVERSTM

INFANT FEVER + PAIN RELIEVER   Acetaminophen

Drug Facts                                          

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.

Ask A Doc

liver disease.

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 24 under 2 Ask a doctor
24-35 2-3 5 mL
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.
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  

Active Ingredient

(in each 5 mL)

Acetaminophen 160 mg

Other Information
  • Store at 20°-25°C (68°-77°F)  

  • AccuSafe® Oral dosing device enclosed

  • Check expiration date on bottle or box before using.
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.

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 i nformation

  • 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

Ask A Doctor Or Pharma

taking the blood thinning drug warfarin.

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

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.


Structured Label Content

Ing

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

Uses

Temporarily:

  • reduces fever

  • relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.
Section 42229-5 (42229-5)

FOR FEVERSTM

INFANT FEVER + PAIN RELIEVER   Acetaminophen

Drug Facts                                          

Purpose

Pain reliever / Fever reducer

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.

Ask A Doc (Ask a doc)

liver disease.

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 24 under 2 Ask a doctor
24-35 2-3 5 mL
Do Not Use (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.
Do Not Use If (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  

Active Ingredient (Active ingredient)

(in each 5 mL)

Acetaminophen 160 mg

Other Information (Other information)
  • Store at 20°-25°C (68°-77°F)  

  • AccuSafe® Oral dosing device enclosed

  • Check expiration date on bottle or box before using.
Other Ingredients (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.

Inactive Ingredients (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 i nformation

  • 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

Ask A Doctor Or Pharma (Ask a doctor or pharma)

taking the blood thinning drug warfarin.

Principal Display Panel (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

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning )

Stop Use and Ask A Doctor If (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. (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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