Mommys Bliss Childrens Pain and Fever

Manufacturer
Mom Enterprises, LLC.
Effective date
2024-04-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:10:59

Label at a glance#

ProductMommys Bliss Childrens Pain and Fever
Active ingredientACETAMINOPHEN
Label structure9 sections

Dosage and administration

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 bott...

Label contents#

Full prescribing information#

Inactive ingredients:

INACTIVE INGREDIENT SECTION

anhydrous citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, natural flavors, organic elderberry juice concentrate, purified water, sodium benzoate, sucrose, xanthan gum

USE:

INDICATIONS & USAGE SECTION

Purpose: Pain reliever/fever reducer

Uses temporarily:
▪ reduces fever
▪ relieves minor aches and pains due to:
▪ the common cold
▪ flu
▪ headache
▪ sore throat
▪ toothache

Directions and Dosing:

DOSAGE & ADMINISTRATION SECTION

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
▪ squeeze dose into the provided dosing cup
▪ 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

Dosing:


Weight (lb) Age (yr) Dose (mL)*
under 24 lbs under 2 years ask a doctor
24-35 lbs 2-3 years 5 mL
36-47 lbs 4-5 years 7.5 mL
48-59 lbs 6-8 years 10 mL
60-71 lbs 9-10 years 12.5 mL
72-95 lbs 11 years 15 mL
*or as directed by a doctor


Attention: use only enclosed cup specifically designed for use with this product. Do not use any other dosing device.

Warnings:

WARNINGS AND PRECAUTIONS SECTION

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)


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.

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.

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

​Active ingredient: (in each 5 mL) Acetaminophen 160mg

WARNINGS:

WARNINGS SECTION

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)

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.

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.

Keep out of reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 and Use:

OTC - PURPOSE SECTION

Purpose:

Pain reliever/fever reducer

Uses temporarily:
▪ reduces fever
▪ relieves minor aches and pains due to:
▪ the common cold
▪ flu
▪ headache
▪ sore throat
▪ toothache

Children's Pain and Fever Acetaminophen 160mg per 5mL oral suspension

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Reliever - Fever Reducer, 4 floz (118 mL) bottle in carton, Ages 2-11 years, Berry Flavor, Dosing Cup Included

cartoncartonlabellabelflapflap

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN4
307668acetaminophen 32 MG/ML Oral SuspensionSCD4
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY4
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY4
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY4
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY4
307668APAP 32 MG/ML Oral SuspensionSY4

DailyMed Product Concepts#

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71444-793-01Mommys Bliss Childrens Pain and Fever118 mL in 1 BOTTLESUSPENSION1184
71444-793-02Mommys Bliss Childrens Pain and Fever236 mL in 1 BOTTLESUSPENSION2364

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71444-793MOMMYS BLISS CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MOM ENTERPRISES, LLC.]4Current NDC, 2 package rows20240415_08b9eaf7-70d1-640f-e063-6394a90a8d3b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71444-79371444-793-02, 71444-793-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mommys Bliss Childrens Pain and FeverACETAMINOPHENMom Enterprises, LLC.08b9eaf7-70d1-640f-e063-6394a90a8d3b2024-04-12WarningsExact identifier
ndc (package): 71444-793-01
ndc (package): 71444-793-02
ndc (product): 71444-793
ndc11 (package): 71444079301
ndc11 (package): 71444079302
spl id: 15ec87b9-3d75-91a6-e063-6294a90a2937
spl set id: 08b9eaf7-70d1-640f-e063-6394a90a8d3b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.