Acetaminophen, Simethicone, Zinc Oxide
FDA Drug Information • Also known as: Little Remedies New Baby Essentials
- Brand Names
- Little Remedies New Baby Essentials
- Dosage Form
- KIT
- Product Type
- HUMAN OTC DRUG
What Is Acetaminophen, Simethicone, Zinc Oxide Used For?
Uses Temporarily: reduces fever relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache. Uses Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food 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.
Dosage and Administration
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 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 24 0.3 mL Children 2 years and over 24 and over 0.6 mL 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.
Warnings and Precautions
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 doc tor before use if the child has liver disease. Ask a doctor or pharma cist 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. Warnings Keep out of reach of children. 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.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.