Principal Display Panel

Principal Display Panel
SPL v4
SPL
SPL Set ID ea31e6ea-243c-408a-a7fd-9d1ea07dd199
Route
ORAL
Published
Effective Date 2024-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Acetaminophen 160 mg


Medication Information

Warnings and Precautions

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.

Indications and Usage

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

Dosage and Administration

this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL = milliliter; FL OZ = fluid ounce only use the dose cup provided find the 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 Weight (lb) Age (yr) Dose (mL)* Under 24 Under 2 Ask a doctor 24-35 2-3 5 mL 36-47 4-5 7.5 mL 48-59 6-8 10 mL 60-71 9-10 12.5 mL 72-95 11 15 mL *or as directed by a doctor

Description

Acetaminophen 160 mg

Section 44425-7

each 5 mL contains: sodium 3 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Section 50565-1

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

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.

Section 50568-5

taking the blood thinning drug warfarin.

Section 50569-3

liver disease.

Section 50570-1

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

Section 51727-6

anhydrous citric acid, FD & C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Section 51945-4

♥CVS Health® Compare to the active ingredient in Children’s Tylenol® Oral Suspension † Oral Suspension Children’s Pain & Fever ACETAMINOPHEN 160 mg / 5 mL Pain reliever; Fever reducer Ages 2 to 11 years Free of added alcohol Aspirin & ibuprofen free No parabens Strawberry Flavor Dosage Cup Included 4 FL OZ (118 mL) DIRECTIONS: Step 1. Shake well before using Step 2. Remove child-protective cap Step 3. Pour your child’s dose into the dosing cup IMPORTANT : Please see dosing chart or ask a doctor for your child’s correct dose. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING † This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Children’s Tylenol® Oral Suspension. 50844   ORG092207936 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2023 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-11112 100% money back guaranteed. CVS.com/returnpolicy CVS 44-079

Section 53413-1

1-800-426-9391

Section 55105-1

Pain reliever/fever reducer

Section 55106-9

Acetaminophen 160 mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL = milliliter; FL OZ = fluid ounce only use the dose cup provided find the 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 Weight (lb) Age (yr) Dose (mL)* Under 24 Under 2 Ask a doctor 24-35 2-3 5 mL 36-47 4-5 7.5 mL 48-59 6-8 10 mL 60-71 9-10 12.5 mL 72-95 11 15 mL *or as directed by a doctor

Warnings and Precautions (34071-1)

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.

Section 44425-7 (44425-7)

each 5 mL contains: sodium 3 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Section 50565-1 (50565-1)

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

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.

Section 50568-5 (50568-5)

taking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

liver disease.

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

anhydrous citric acid, FD & C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Section 51945-4 (51945-4)

♥CVS Health® Compare to the active ingredient in Children’s Tylenol® Oral Suspension † Oral Suspension Children’s Pain & Fever ACETAMINOPHEN 160 mg / 5 mL Pain reliever; Fever reducer Ages 2 to 11 years Free of added alcohol Aspirin & ibuprofen free No parabens Strawberry Flavor Dosage Cup Included 4 FL OZ (118 mL) DIRECTIONS: Step 1. Shake well before using Step 2. Remove child-protective cap Step 3. Pour your child’s dose into the dosing cup IMPORTANT : Please see dosing chart or ask a doctor for your child’s correct dose. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING † This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Children’s Tylenol® Oral Suspension. 50844   ORG092207936 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2023 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-11112 100% money back guaranteed. CVS.com/returnpolicy CVS 44-079

Section 53413-1 (53413-1)

1-800-426-9391

Section 55105-1 (55105-1)

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Acetaminophen 160 mg


Raw Label Data

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