MOMMYS BLISS CHILDRENS PAIN AND FEVER- acetaminophen suspension

Mommys Bliss Childrens Pain and Fever by

Drug Labeling and Warnings

Mommys Bliss Childrens Pain and Fever by is a Otc medication manufactured, distributed, or labeled by Mom Enterprises, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Inactive ingredients:

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

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

Directions and Dosing:

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:

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:

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

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)

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.

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:

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

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

INGREDIENTS AND APPEARANCE

MOMMYS BLISS CHILDRENS PAIN AND FEVER 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71444-793
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
AMERICAN ELDERBERRY (UNII: 7610Y219OC)

Product Characteristics
Color	purple (purple to brown liquid)	Score
Shape		Size
Flavor	BERRY (berry flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71444-793-02	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/19/2024
2	NDC: 71444-793-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/19/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	02/19/2024

Labeler - Mom Enterprises, LLC. (135903776)