Children's Tylenol Suspension: Package Insert / Prescribing Information - Drugs.com

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# Children's Tylenol Suspension

Package insert / prescribing information
Generic name: acetaminophen
Dosage form: oral suspension
Drug class: Miscellaneous analgesics

Medically reviewed by Drugs.com. Last updated on Sep 21, 2022.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

## Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

## Purpose

Pain reliever/fever reducer

## Uses

temporarily:

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

## 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

### 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 or pharmacist 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
- new symptoms occur
- redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

### Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. 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.

## 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
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor

Weight (lb) | Age (yr) | Dose (tsp or mL)
--- | --- | ---
under 24 | under 2 years | ask a doctor
24-35 | 2-3 years | 1 tsp or 5 mL
36-47 | 4-5 years | 1 ½ tsp or 7.5 mL
48-59 | 6-8 years | 2 tsp or 10 mL
60-71 | 9-10 years | 2 ½ tsp or 12.5 mL
72-95 | 11 years | 3 tsp or 15 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

## Other information

- each teaspoon contains: sodium 2 mg
- store between 20-25°C (68-77°F)
- do not use if neck wrap or foil inner seal imprinted with "Safety Seal®" is broken or missing
- see bottom panel for lot number and expiration date

## Inactive ingredients

anhydrous citric acid, butylparaben, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, xanthan gum

## Questions or comments?

call 1-877-895-3665

## PRINCIPAL DISPLAY PANEL

See New Warnings Information

NDC 50580-318-10

Children's
TYLENOL®

Acetaminophen
Oral Suspension
Fever Reducer, Pain Reliever

AGES 2-11

Pediatricians'
1st Choice

Alcohol Free
Aspirin Free
Ibuprofen Free

grape
FLAVOR

3.38 FL OZ (100mL)
80 mg per 1/2 teaspoon
(160 mg per 5 mL)

CHILDRENS TYLENOL acetaminophen suspension

Product Information
Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC:50580-318
Route of Administration | ORAL | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
acetaminophen (acetaminophen) | acetaminophen | 160 mg in 5 mL

Inactive Ingredients
Ingredient Name | Strength
anhydrous citric acid |
butylparaben |
D&C red NO. 33 |
FD&C blue NO. 1 |
glycerin |
high fructose corn syrup |
cellulose, microcrystalline |
carboxymethylcellulose sodium |
propylene glycol |
water |
sodium benzoate |
xanthan gum |

Product Characteristics
Color | PURPLE | Score |
Shape |  | Size |
Flavor | GRAPE | Imprint Code |
Contains |

Packaging
# | Item Code | Package Description
1 | NDC:50580-318-10 | 1 BOTTLE (BOTTLE) in 1 CARTON
1 |  | 100 mL in 1 BOTTLE
2 | NDC:50580-318-20 | 2 BOTTLE (BOTTLE) in 1 PACKAGE
2 |  | 100 mL in 1 BOTTLE

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
OTC MONOGRAPH NOT FINAL | part343 | 07/30/2010 |

Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

McNeil Consumer Healthcare Div McNeil-PPC, Inc

## Frequently asked questions

- What's the best sore throat medicine to use?
- What medications cause liver enzymes to be elevated?
- Which painkiller should you use?
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- Advil (ibuprofen) & Tylenol (acetaminophen) together, is it safe?
- How long does it take for Tylenol to start working?

## More about Children's Tylenol (acetaminophen)

- Check interactions
- Pricing & coupons
- Drug images
- Latest FDA alerts (21)
- Side effects
- Dosage information
- During pregnancy
- Drug class: miscellaneous analgesics
- Breastfeeding
- En español

### Patient resources

- Drug Information
- Children's Tylenol Meltaways
- Tylenol Children's

### Professional resources

- Prescribing Information
- Acetaminophen Injection (FDA)

#### Other brands

Ofirmev, 7T Gummy ES Chewable Tablets

### Other formulations

- Tylenol

### Related treatment guides

- Fever
- Pain

Medical Disclaimer