Mommys Bliss Infants Pain And Fever Suspension
FDA Label NDC 71444-893

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mom Enterprises, Llc. for the product Mommys Bliss Infants Pain And Fever (NDC 71444-893). 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: (in each 5 ml) acetaminophen 160mg, keep out of reach of children. overdose warning: in case of overdose, get medical help or contact a poison control center right away. (1-800-222-1222) prompt medical attention is critical even if you do not notice any signs or symptoms., purpose: pain reliever/fever reducer uses temporarily: ▪ reduces fever ▪ relieves minor aches and pains due to: ▪ the common cold ▪ flu ▪ headache ▪ sore throat ▪ toothache, stop use and ask a doctor if: ▪ pain gets worse or lasts more than 5 days ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ any new symptoms appear these could be signs of a serious condition., inactive ingredients anhydrous citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, natural flavors, organic elderberry juice concentrate, purified water, sodium benzoate, sucrose, xanthan gum, 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 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. sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use: ▪ with any other drug containing acetaminophen (prescription or nonprescription.) 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 doctor before use if your child has liver disease ask a doctor before use if your child is taking the blood thinning drug warfarin when using this product do not exceed recommended dose (see overdose warning), dosing & directions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ 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 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. Sore Throat Warning: If Sore Throat Is Severe, Persists For More Than 2 Days, Is Accompanied Or Followed By Fever, Headache, Rash, Nausea, Or Vomiting, Consult A Doctor Promptly. Do Not Use: ▪ With Any Other Drug Containing Acetaminophen (prescription Or Nonprescription.) 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 Doctor Before Use If Your Child Has Liver Disease Ask A Doctor Before Use If Your Child Is Taking The Blood Thinning Drug Warfarin When Using This Product Do Not Exceed Recommended Dose (see Overdose Warning)

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