DR. SANA PAIN AND FEVER FOR CHILDREN- acetaminophen syrup

DR. SANA PAIN AND FEVER FOR Children by

Drug Labeling and Warnings

DR. SANA PAIN AND FEVER FOR Children by is a Otc medication manufactured, distributed, or labeled by GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

pain relief, 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.

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 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

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.

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.

mL=milliliter

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

Other information:

Store between 20-25℃ (68-77˚F)
Don't use if carton tape or bottle wrap imprinted with is broken or missing

Inactive Ingredients

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: 305-633-7900

SPL UNCLASSIFIED SECTION

 Fever Reducer​
Pain Reliever

NO ALCOHOL ​ NO GLUTEN

SHAKE WELL BEFORE USING

Distributed by:

Healthtex Distributors, LLC
Miami, Florida 33142
info@healthtexusa.com

Made in USA

Packaging

INGREDIENTS AND APPEARANCE

DR. SANA PAIN AND FEVER FOR CHILDREN 
acetaminophen syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-516
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-516-06	1 in 1 BOX	04/14/2025
1		180 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	04/14/2025

Labeler - GADAL Laboratories, Inc (841305639)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	manufacture(53113-516)