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| Product NDC Code | 71444-893 | ||||
|---|---|---|---|---|---|
| Drug Name | Mommys bliss infants pain and fever |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SUSPENSION | ||||
| RxCUI drug identifier | 307668 | ||||
| Application Number | M013 | ||||
| Labeler Name | Mom Enterprises, LLC. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Active ingredient: (in each 5 mL) Acetaminophen 160mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Dosing & Directions Directions ▪ this product does not contain directions or complete warnings for adult use ▪ do not give more than directed (see overdose warning) ▪ shake well before using ▪ mL=milliliter ▪ find right dose on chart below ▪ if possible, use weight to dose; otherwise, use age ▪ remove cap and seal, then insert the adapter plug by pushing down firmly until a tight seal is formed ▪ top of plug should be flush with bottle neck and not removeable ▪ push air out of syringe and insert syringe tip into adapter plug opening ▪ flip bottle upside down ▪ pull plunger of syringe up to correct dose ▪ dispense liquid slowly into child’s mouth, toward inner cheek ▪ repeat dose every 4 hours while symptoms last ▪ do not give more than 5 times in 24 hours ▪ replace cap tightly to maintain child resistance Weight (lb) Age (yr) Dose (mL)* under 24 lbs under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL *or as directed by a doctor Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: anhydrous citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, natural flavors, organic elderberry juice concentrate, purified water, sodium benzoate, sucrose, xanthan gum
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Usage Purpose: Pain reliever/fever reducer Uses temporarily: ▪ reduces fever ▪ relieves minor aches and pains due to: ▪ the common cold ▪ flu ▪ headache ▪ sore throat ▪ toothache
Purpose
Information about the drug product’s indications for use.Purpose: Pain reliever/fever reducer Uses temporarily: ▪ reduces fever ▪ relieves minor aches and pains due to: ▪ the common cold ▪ flu ▪ headache ▪ sore throat ▪ toothache
Spl product data elements
Usually a list of ingredients in a drug product.Mommys Bliss Infants Pain and Fever Acetaminophen WATER CARBOXYMETHYLCELLULOSE SODIUM AMERICAN ELDERBERRY XANTHAN GUM SODIUM BENZOATE ANHYDROUS CITRIC ACID ACETAMINOPHEN ACETAMINOPHEN GLYCERIN SUCROSE sweet berry flavor light purple to light brown liquid
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Infants' Pain and Fever Acetaminophen 160mg per 5mL oral suspension Pain Reliever - Fever Reducer, 2 floz (59 mL) plastic bottle in retail carton, Natural Berry Flavor, Dosing Syringe included retail carton bottle flap
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor. 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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings 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)
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API