Active Ingredient
(in each 5 mL)
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Little Remedies New Baby Essentials (NDC 63029-615). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if the child has, ask a doctor or pharmacist before use if the child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each 5 mL)
Acetaminophen 160 mg
Pain reliever / Fever reducer
Antigas
Temporarily:
Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food
–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.
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.
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
liver disease.
taking the blood thinning drug warfarin.
do not exceed recommended dose (see overdose warning)
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.
In some infants, a rare allergic reaction may occur. Do not exceed recommended dosage.
▪ The use of this dispenser by more than one person may spread infection.
▪ Wipe nozzle clean after each use.
This product does not contain directions or complete warnings for adult use.
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
■ 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 24 | 0.3 mL |
| Children 2 years and over | 24 and over | 0.6 mL |
(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.
■ do not freeze ■ store at room temperature 20˚-25˚C (68˚-77˚F)
■ See bottle or box for lot number and expiration date
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 |
|
|
| 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 |
|
|
|
| Other information |
|
|
|
| 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
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 | |
Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg
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.
▪ 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
water, sodium chloride, glycerin, sodium benzoate, benzoic acid
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 Panellittle Remedies®new Baby Essentials Kitinfant Fever/pain Reliever Acetaminophen / Fever/pain Reliever 2 Fl Oz (59 mL)syringe Includedgas Dropssimethicone /antigas1 Fl Oz (30 mL)syringe Includeddiaper Rash Ointment Zinc Oxide / Skin Protectant 2 Oz (57 G) Saline Spray + Drops 0.5 Fl Oz (15 mL)gripe Water Ginger / Fennel Supplement2 Fl Oz (59 mL)syringe Includednasal Aspirator (Little Remedies New Baby Essentials Kit 01)
* Please review the disclaimer below.