Indications and uses
Temporarily: reduces fever relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.
Temporarily: reduces fever relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.
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 inv...
FOR FEVERSTM
INFANT FEVER + PAIN RELIEVER Acetaminophen
Drug Facts
(in each 5 mL)
Acetaminophen 160 mg
Pain reliever / Fever reducer
Temporarily:
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.
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 |
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 |
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| 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 |
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| Other information |
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| Inactive ingredients castor oil, mineral oil, paraffin, peruvian balsam, white petrolatum |
| Questions? |
| 1-855-785-2888 |
FOR TUMMYSTM
GAS RELIEF DROPS Simethicone / Antigas
Drug Facts
Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg
Antigas
Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food
■ 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 |
■ do not freeze ■ store at room temperature 20˚-25˚C (68˚-77˚F)
■ See bottle or box for lot number and expiration date
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 | |
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.
In some infants, a rare allergic reaction may occur. Do not exceed recommended dosage.
▪ 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
–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.
▪ The use of this dispenser by more than one person may spread infection.
▪ Wipe nozzle clean after each use.
(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.
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
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | 2 |
| 198857 | simethicone 20 MG in 0.3 mL Oral Suspension | PSN | 2 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | 2 |
| 198857 | simethicone 66.7 MG/ML Oral Suspension | SCD | 2 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | 2 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | 2 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | 2 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | 2 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | 2 |
| 198857 | simethicone 20 MG per 0.3 ML Oral Suspension | SY | 2 |
| 198857 | simethicone 40 MG per 0.6 ML Oral Suspension | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DIMETHICONE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| GINGER Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63029-615-01 | LITTLE REMEDIES NEW BABY ESSENTIALS | 1 in 1 CARTON | KIT | 1 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63029-615 | 63029-615-01 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| LITTLE REMEDIES NEW BABY ESSENTIALS | ACETAMINOPHEN, SIMETHICONE, ZINC OXIDE | Medtech Products Inc. | 4b1b7294-aca6-45fa-a008-c1869131b2a3 | 2024-12-06 | Warnings | 63029-615-01 63029-615 63029061501 e64d548a-a9e1-430b-9091-628e8db105dc 4b1b7294-aca6-45fa-a008-c1869131b2a3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.