SPL v1
SPL
SPL Set ID bdc48d22-c606-665e-e053-2995a90a9dbe
Route
ORAL
Published
Effective Date 2021-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Citric Acid Monohydrate Sodium Benzoate Sodium Citrate Sorbitol Fd&c Red No. 40 Glycerin Polyethylene Glycol 400 Water Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-17

Description

Active ingredient (per 5mL teaspoonful) Acetaminophen 160 mg


Medication Information

Description

Active ingredient (per 5mL teaspoonful) Acetaminophen 160 mg

Uses

temporarily • relieves minor aches • reduces fever

Section 50567-7

When using this product: Do not exceed recommended dose.

Section 50568-5

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if your child has a liver disease.

Section 55105-1

Pain Reliever / Fever Reducer

Section 55106-9

Active ingredient (per 5mL teaspoonful)

Acetaminophen 160 mg

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 • taken 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.

Directions

• do not take more than directed

This product does not contain directions or complete warnings for adult use.

• find dose in chart below, if possible, use weight to dose, otherwise use age

• dosage may be repeated every 4 hours as needed, or as directed by a doctor

• do not give more than 5 doses in 24 hours • 5 milliliters (mL) = 1 teaspoon

Weight (lb)

Under 24

24-36

36-47

48-59

60-71

72-95

age (yr)

Under 2

2-3

4-5

6-8

9-10

11

Dosage (mL)

ask a doctor

5 mL

7.5 mL

10 mL

12.5 mL

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

Other Information

• each teaspoonful (5 mL) contains: sodium 7.9 mg

• store at room temperature 15°- 30°C (59°-86°F)

• protect from freezing • protect from light

TAMPER-EVIDENT: Do not use if imprinted seal under cap is broken or missing.

Inactive Ingredients:

artificial cherry flavor, citric acid, FD&C Red #40, glycerin, PEG, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol.

Principal Display Panel

• Compare To Active ingredient of Children's Tylenol

NDC 72091-004-01

Children's Liquid

Pain Reliever and Fever Reducer

Acetaminophen 160 mg/5mL

• Asprin Free

• Alcohol Free

• For Children Ages 2 - 11 years

Fruit Flavor

8 FL OZ (237 mL)

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.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.


Structured Label Content

Uses

temporarily • relieves minor aches • reduces fever

Section 50567-7 (50567-7)

When using this product: Do not exceed recommended dose.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if your child has a liver disease.

Section 55105-1 (55105-1)

Pain Reliever / Fever Reducer

Section 55106-9 (55106-9)

Active ingredient (per 5mL teaspoonful)

Acetaminophen 160 mg

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 • taken 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.

Directions

• do not take more than directed

This product does not contain directions or complete warnings for adult use.

• find dose in chart below, if possible, use weight to dose, otherwise use age

• dosage may be repeated every 4 hours as needed, or as directed by a doctor

• do not give more than 5 doses in 24 hours • 5 milliliters (mL) = 1 teaspoon

Weight (lb)

Under 24

24-36

36-47

48-59

60-71

72-95

age (yr)

Under 2

2-3

4-5

6-8

9-10

11

Dosage (mL)

ask a doctor

5 mL

7.5 mL

10 mL

12.5 mL

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

Other Information (Other information)

• each teaspoonful (5 mL) contains: sodium 7.9 mg

• store at room temperature 15°- 30°C (59°-86°F)

• protect from freezing • protect from light

TAMPER-EVIDENT: Do not use if imprinted seal under cap is broken or missing.

Inactive Ingredients: (Inactive ingredients:)

artificial cherry flavor, citric acid, FD&C Red #40, glycerin, PEG, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

• Compare To Active ingredient of Children's Tylenol

NDC 72091-004-01

Children's Liquid

Pain Reliever and Fever Reducer

Acetaminophen 160 mg/5mL

• Asprin Free

• Alcohol Free

• For Children Ages 2 - 11 years

Fruit Flavor

8 FL OZ (237 mL)

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.)

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.


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