DR. SANA PAIN AND FEVER FOR Children

Product NDC
53113-516
11-digit product format
531130516
Labeler code
53113
Product ID
53113-516_d3ebeaac-ec26-4f27-be5d-739918117f2f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SYRUP
Route
ORAL
Labeler
GADAL Laboratories, Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-14
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DR. SANA PAIN AND FEVER FOR ChildrenACETAMINOPHENGADAL Laboratories, Inc8a22a5ba-8623-4cca-8723-52b4954034612025-07-23WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

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.

Additional Listing Data#

Finished product
Yes
Brand name base
DR. SANA PAIN AND FEVER FOR Children
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui307675

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53113-516-06DR. SANA PAIN AND FEVER FOR Children1 in 1 BOXSYRUP12
53113-516-06DR. SANA PAIN AND FEVER FOR Children180 mL in 1 BOTTLESYRUP1802

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN8a22a5ba-8623-4cca-8723-52b4954034612
307675acetaminophen 32 MG/ML Oral SolutionSCD8a22a5ba-8623-4cca-8723-52b4954034612
307675acetaminophen 160 MG per 5 ML Oral SolutionSY8a22a5ba-8623-4cca-8723-52b4954034612
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY8a22a5ba-8623-4cca-8723-52b4954034612
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY8a22a5ba-8623-4cca-8723-52b4954034612
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY8a22a5ba-8623-4cca-8723-52b4954034612
307675APAP 32 MG/ML Oral SolutionSY8a22a5ba-8623-4cca-8723-52b4954034612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53113-516-06531130516061 BOTTLE in 1 BOX (53113-516-06) / 180 mL in 1 BOTTLE1 bottle2025-04-14NoNoCurrent