Dr. Sana

Dr. Sana
SPL v2
SPL
SPL Set ID 8a22a5ba-8623-4cca-8723-52b495403461
Route
ORAL
Published
Effective Date 2025-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Citric Acid Monohydrate Corn Syrup Fd&c Red No. 40 Glycerin Hydroxyethyl Cellulose, Unspecified Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sorbitol Solution Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-14

Description

Acetaminophen 160 mg

Purpose

pain relief, fever reducer


Medication Information

Purpose

pain relief, fever reducer

Description

Acetaminophen 160 mg

Uses

temporarily:

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

Section 42229-5

• Fever Reducer

Pain Reliever

NO ALCOHOL ​• NO GLUTEN

SHAKE WELL BEFORE USING

Distributed by:

Healthtex Distributors, LLC

Miami, Florida 33142

[email protected]

Made in USA

Section 50565-1

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.

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.

Packaging

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

Drug Facts

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

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg


Structured Label Content

Uses

temporarily:

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

Section 42229-5 (42229-5)

• Fever Reducer

Pain Reliever

NO ALCOHOL ​• NO GLUTEN

SHAKE WELL BEFORE USING

Distributed by:

Healthtex Distributors, LLC

Miami, Florida 33142

[email protected]

Made in USA

Section 50565-1 (50565-1)

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.

Purpose

pain relief, fever reducer

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.

Packaging

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

Drug Facts

Other Information: (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? (Questions or comments?)

Call weekdays from 9:30 AM to 5 PM EST at Tel: 305-633-7900

Active Ingredient (in Each 5 Ml) (Active Ingredient (in each 5 mL))

Acetaminophen 160 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)