mommys bliss infants pain and fever

mommys bliss infants pain and fever
SPL v4
SPL
SPL Set ID 05e26650-81b3-d7b1-e063-6394a90a14ed
Route
oral
Published
Effective Date 2024-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (160 mg)
Inactive Ingredients
water carboxymethylcellulose sodium american elderberry xanthan gum sodium benzoate anhydrous citric acid glycerin sucrose

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
otc monograph drug active Since 2024-02-19

Purpose

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

Description

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


Medication Information

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)

Purpose

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

Description

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

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:

Pain reliever/fever reducer



Uses temporarily:

▪ reduces fever

▪ relieves minor aches and pains due to:

▪ the common cold

▪ flu

▪ headache

▪ sore throat

▪ toothache

Active Ingredient

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

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 Ingredients:

anhydrous citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, natural flavors, organic elderberry juice

concentrate, purified water, sodium benzoate, sucrose, xanthan gum

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.

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.

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


Structured Label Content

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)

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:

Pain reliever/fever reducer



Uses temporarily:

▪ reduces fever

▪ relieves minor aches and pains due to:

▪ the common cold

▪ flu

▪ headache

▪ sore throat

▪ toothache

Active Ingredient

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

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 Ingredients: (Inactive ingredients:)

anhydrous citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, natural flavors, organic elderberry juice

concentrate, purified water, sodium benzoate, sucrose, xanthan gum

Stop Use and Ask A Doctor. (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.

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.

Infants' Pain and Fever Acetaminophen 160mg Per 5ml Oral Suspension (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


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