DE LA CRUZ DOLOFEBRIL INFANT - acetaminophen suspension
DLC Laboratories, Inc

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.

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Active ingredient (in each 0.8ml)

Acetaminophen 80mg

Purpose

Pain reliever/ fever reducer

Uses:

temporarily:

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

Warnings

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 product containing acetaminophen

Stop use and ask a doctor if

new symptoms occur
redness or swelling is present
pain gets worse or lasts for more than 5 days
fever gest worse or lasts for more than 3 days

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. quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

Do not exceed recommended dose (see overdose warning)
Shake well before using
find right dose on chart below. If possible, use weight to dose; otherwise use age
if needed, repeat dose every 4 hours
do not use more than 5 times in 24 hours
only use enclosed measuring cup

Dosing Table
Weight (lb)	Age (Years)	Dose (teaspoons
under 24	under 2	ask a doctor
24-35	2-3	1.6mL (0.8 + 0.8mL)

Attention: Specifically designed for use with the enclosed measuring cup. Do not use any other dosing device.

Other Information

Each teaspoon contains: sodium 2mg

Do not use if bottle wrap is broken or missing

Store between 15-20 degreesC (59-86degreesC)

see bottom panel for lot number and exipiration date.

Inactive Ingredients

purified water U.S.P., natural strawberry flavor, hydroxypropyl methylcellulose, xanthan gum, sodium benzoate, glycerin, sucralose, citric acid, sorbitol, high fructose corn syrup, FDandC Red No. 40

Questions or comments?

Call toll free 1-800-858-3889 or www.dlclaboratories.com

Distributed by:

De La Cruz Products

A Division of DLC Laboratories, Inc.

Paramount, CA 90723

Package Labeling

Dolofebril
For Pain and Fever

Free of Alcohol, Aspirin and Ibuprofen

Infants
Strawberry Flavor

Dolofebril Childrens

DE LA CRUZ DOLOFEBRIL INFANT
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24286-1545
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	80 mg in 0.8 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
XANTHAN GUM
SODIUM BENZOATE
GLYCERIN
SUCRALOSE
CITRIC ACID MONOHYDRATE
SORBITOL
HIGH FRUCTOSE CORN SYRUP
FD&C RED NO. 40

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:24286-1545-1	30 mL in 1 BOTTLE, DROPPER	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/27/2012	02/27/2012

Labeler - DLC Laboratories, Inc (093351930)

Revised: 02/2012 DLC Laboratories, Inc