Novalgina Acetaminophen Pain And Fever For Children's

Novalgina Acetaminophen Pain And Fever For Children's
SPL v4
SPL
SPL Set ID fa2dc6d6-7e79-46f7-e053-6294a90aeae2
Route
ORAL
Published
Effective Date 2023-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Corn Syrup Citric Acid Monohydrate Water Sucralose Sorbitol Propylene Glycol Sodium Citrate Fd&c Red No. 40 Hydroxyethyl Cellulose (100 Mpa.s At 2%) Glycerin Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-08

Description

Acetaminophen, 160mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen, 160mg

Uses

temporarily:

■ reduces fever

■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache

Package

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 for this product

■ 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, persistent for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. Consult a doctor promptly.

Directions



Do not give more than directed, this product does not contain directions or complete warnings for adult use, find right dose on

chart below. If possible, use weight to dose; otherwise, use age. Repeat dose every 4 hours while symptoms last, do not give more than 5 times in 24 hours. Attention use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Weight (lbs) Age (Years) Dose
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
48-59 lbs. 6-10 Years

10 mL

60-71 lbs 9-10 years

12.5 mL

72-95 lbs 11 years 15 ml

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.

Overdose Warning



In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222- 1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient

Acetaminophen, 160mg

Other Information

■ Store between 20-25°C (68-77°F)

■ Don’t use if carton tape or bottle wrap imprinted with is broken or missing







Inactive Ingredient



Citric acid, corn syrup, FD&C red no. 40, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben,

purified water, sodium citrate, sorbitol solution, natural and artificial strawberry flavor, sucralose.

Questions Or Comments?



Call weekdays from 9:30 AM to 5 PM EST at Tel: 305 2618762

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 ■ new symptoms occur ■ redness or swelling is present. 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)

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If Your Child

has liver disease

Ask A Doctor Or Pharmacist Before Use If Your

child is taking the blood thinning drug warfarin


Structured Label Content

Uses

temporarily:

■ reduces fever

■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache

Package

Purpose

Pain reliever/fever reducer

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 for this product

■ 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, persistent for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. Consult a doctor promptly.

Directions



Do not give more than directed, this product does not contain directions or complete warnings for adult use, find right dose on

chart below. If possible, use weight to dose; otherwise, use age. Repeat dose every 4 hours while symptoms last, do not give more than 5 times in 24 hours. Attention use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Weight (lbs) Age (Years) Dose
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
48-59 lbs. 6-10 Years

10 mL

60-71 lbs 9-10 years

12.5 mL

72-95 lbs 11 years 15 ml

Do Not Use (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.

Overdose Warning (Overdose warning)



In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222- 1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient

Acetaminophen, 160mg

Other Information

■ Store between 20-25°C (68-77°F)

■ Don’t use if carton tape or bottle wrap imprinted with is broken or missing







Inactive Ingredient



Citric acid, corn syrup, FD&C red no. 40, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben,

purified water, sodium citrate, sorbitol solution, natural and artificial strawberry flavor, sucralose.

Questions Or Comments? (Questions or Comments?)



Call weekdays from 9:30 AM to 5 PM EST at Tel: 305 2618762

Stop Use and Ask A Doctor If (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 ■ new symptoms occur ■ redness or swelling is present. 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)

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If Your Child (Ask a doctor before use if your child)

has liver disease

Ask A Doctor Or Pharmacist Before Use If Your (Ask a doctor or pharmacist before use if your)

child is taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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