Children’s Pain Relief Acetaminophen 160mg Dye Free Bubblegum Flavor Chewable Tablets

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Citric Acid Monohydrate Crospovidone (120 .mu.m) Dextrose, Unspecified Form Magnesium Stearate Maltodextrin Starch, Corn Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: RP160 Shape: round Color: white Size: 16 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-11-01

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Uses

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

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

Directions

this product does not contain directions or complete warnings for adult use.
do not give more than directed (see overdose warning)
find the right dose on chart below. If possible, use weight to dose; otherwise use age.
chew before swallowing
if needed, repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lbs)	under 24	24-35	36-47	48-59	60-71	72-95
Age (yrs)	under 2 years	2-3- years	4-5 years	6-8 years	9-10 years	11 years
Dose(tablets)*	ask a doctor	1	1 1/2	2	2 1/2	3

*or as directed by a doctor

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.

Other Information

store at room temperature Avoid high humidity.
see end flap for expiration date and lot number
keep this carton for future reference on full labeling

Inactive Ingredients

citric acid, crospovidone, dextrose, flavor, magnesium stearate, maltodextrin, starch, sucralose

Questions Or Comments?

1-866-467-2748

Principal Display Panel

NDC 69842-160-24

Compare to the active ingredient in Children’s Tylenol ^®Chewables†

Children’s

Pain Relief

Acetaminophen 160 mg

Pain reliever/Fever reducer

Ages 2-11

Free of: Aspirin & Ibuprofen

BUBBLEGUM FLAVOR

24 CHEWABLE TABLETS

160 mg each

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children’s Tylenol ^®Chewables.

Distributed by: CVS Pharmacy, Inc,

One CVS Drive, Woonsocket, RI 02895

CVS.com 1-800-SHOP CVS

When Using This Product

do not exceed recommended dose (see overdose warning)

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: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 at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Active Ingredient (in Each Tablet)

Acetaminophen 160 mg

Ask A Doctor Before Use If Your Child Has

liver disease.

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin.

Structured Label Content

Uses

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

Purpose

Pain reliever/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

Directions

this product does not contain directions or complete warnings for adult use.
do not give more than directed (see overdose warning)
find the right dose on chart below. If possible, use weight to dose; otherwise use age.
chew before swallowing
if needed, repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lbs)	under 24	24-35	36-47	48-59	60-71	72-95
Age (yrs)	under 2 years	2-3- years	4-5 years	6-8 years	9-10 years	11 years
Dose(tablets)*	ask a doctor	1	1 1/2	2	2 1/2	3

*or as directed by a doctor

Do Not Use (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.

Other Information (Other information)

store at room temperature Avoid high humidity.
see end flap for expiration date and lot number
keep this carton for future reference on full labeling

Inactive Ingredients (Inactive ingredients)

citric acid, crospovidone, dextrose, flavor, magnesium stearate, maltodextrin, starch, sucralose

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

NDC 69842-160-24

Compare to the active ingredient in Children’s Tylenol ^®Chewables†

Children’s

Pain Relief

Acetaminophen 160 mg

Pain reliever/Fever reducer

Ages 2-11

Free of: Aspirin & Ibuprofen

BUBBLEGUM FLAVOR

24 CHEWABLE TABLETS

160 mg each

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children’s Tylenol ^®Chewables.

Distributed by: CVS Pharmacy, Inc,

One CVS Drive, Woonsocket, RI 02895

CVS.com 1-800-SHOP CVS

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)

Stop Use and Ask A Doctor If (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. (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 at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Acetaminophen 160 mg

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease.

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache temporarily reduces fever", "Purpose": "Pain reliever/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: a cetaminophen 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", "Directions": "this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning) find the right dose on chart below. If possible, use weight to dose; otherwise use age. chew before swallowing if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lbs) under 24 24-35 36-47 48-59 60-71 72-95 Age (yrs) under 2 years 2-3- years 4-5 years 6-8 years 9-10 years 11 years Dose(tablets)* ask a doctor 1 1 1/2 2 2 1/2 3 *or as directed by a doctor", "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.", "Other information": "store at room temperature Avoid high humidity. see end flap for expiration date and lot number keep this carton for future reference on full labeling", "Inactive ingredients": "citric acid, crospovidone, dextrose, flavor, magnesium stearate, maltodextrin, starch, sucralose", "Questions or comments?": "1-866-467-2748", "Principal Display Panel": "NDC 69842-160-24 Compare to the active ingredient in Children’s Tylenol ® Chewables† Children’s Pain Relief Acetaminophen 160 mg Pain reliever/Fever reducer Ages 2-11 Free of: Aspirin & Ibuprofen BUBBLEGUM FLAVOR 24 CHEWABLE TABLETS 160 mg each TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING †This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children’s Tylenol ® Chewables. Distributed by: CVS Pharmacy, Inc, One CVS Drive, Woonsocket, RI 02895 ©2017 CVS/Pharmacy CVS.com 1-800-SHOP CVS", "When using this product": "do not exceed recommended dose (see overdose warning)", "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: 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 at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.", "Active ingredient (in each tablet)": "Acetaminophen 160 mg", "Ask a doctor before use if your child has": "liver disease.", "Ask a doctor or pharmacist before use if your child is": "taking the blood thinning drug warfarin."}

Children’s Pain Relief Acetaminophen 160mg Dye Free Bubblegum Flavor Chewable Tablets

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information