MOMMYS BLISS INFANTS PAIN AND FEVER- acetaminophen suspension

Mommys Bliss Infants Pain and Fever by

Drug Labeling and Warnings

Mommys Bliss Infants 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]

Active Ingredient

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.

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

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

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.

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

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

INGREDIENTS AND APPEARANCE

MOMMYS BLISS INFANTS PAIN AND FEVER 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71444-893
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
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
AMERICAN ELDERBERRY (UNII: 7610Y219OC)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
SUCROSE (UNII: C151H8M554)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71444-893-01	59 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)