Family Wellness Childrens Pain Reliever 574

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Butylparaben Anhydrous Citric Acid Glycerin Maltitol Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Propylene Glycol Propylparaben Sucralose Xanthan Gum Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-04-18

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160mg

Use(s)

temporarily:

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if the 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, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

do not give more than directed (see overdose warning)
shake well before use
this product does not contain directions or complete warning for adult dose
use only with enclosed dosing cup
repeat dose every 4 hours while symptoms last
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
mL = milliliter

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

Do Not Use

with any other product containing acetaminophen (prescription or non-prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Other Information

store between 20-25ºC (68-77ºF)

Active Ingredient(s)

Acetaminophen 160mg

Inactive Ingredients

butylparaben, citric acid, flavor, glycerin, maltitol, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sucralose, Xanthan gum.

Questions Or Comments?

Call 1-609-860-2600 (Monday - Friday 8 am - 4 pm)

Principal Display Panel

FAMILY Wellness^TM

COMPARE TO THE ACTIVE INGREDIENT IN CHILDRENS TYLENOL® LIQUID*

children's PAIN RELIEVEER

AGE 2 - 11 YEARS

ACETAMINOPHEN 160 mg per 5 mL

Oral Suspension Liquid

PAIN RELIEVER/FEVER REDUCER

Alcohol Free
Aspirin Free
Ibuprofen Free

DYE-FREE

CHERRY FLAVOR

4 FL OZ (118 mL)

When Using This Product

do not exceed recommended dose (see overdose warning)

Stop Use and Ask Doctor If

pain gets worse or last 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. Quick medical attention is critical even if you do not notice any signs or symptoms.

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

Use(s) (USE(S))

temporarily:

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

Purpose (PURPOSE)

Pain reliever/fever reducer

Warnings (WARNINGS)

Liver warning: This product contains acetaminophen. Severe liver damage may occur if the 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, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions (DIRECTIONS)

do not give more than directed (see overdose warning)
shake well before use
this product does not contain directions or complete warning for adult dose
use only with enclosed dosing cup
repeat dose every 4 hours while symptoms last
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
mL = milliliter

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

Do Not Use (DO NOT USE)

with any other product containing acetaminophen (prescription or non-prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Other Information (OTHER INFORMATION)

store between 20-25ºC (68-77ºF)

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Acetaminophen 160mg

Inactive Ingredients (INACTIVE INGREDIENTS)

butylparaben, citric acid, flavor, glycerin, maltitol, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sucralose, Xanthan gum.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-609-860-2600 (Monday - Friday 8 am - 4 pm)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

FAMILY Wellness^TM

COMPARE TO THE ACTIVE INGREDIENT IN CHILDRENS TYLENOL® LIQUID*

children's PAIN RELIEVEER

AGE 2 - 11 YEARS

ACETAMINOPHEN 160 mg per 5 mL

Oral Suspension Liquid

PAIN RELIEVER/FEVER REDUCER

Alcohol Free
Aspirin Free
Ibuprofen Free

DYE-FREE

CHERRY FLAVOR

4 FL OZ (118 mL)

When Using This Product (WHEN USING THIS PRODUCT)

do not exceed recommended dose (see overdose warning)

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

pain gets worse or last 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. Quick medical attention is critical even if you do not notice any signs or symptoms.

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)

{"USE(S)": "temporarily: reduces fever relieves minor aches and pains due to: the common cold sore throat flu toothache headache", "PURPOSE": "Pain reliever/fever reducer", "WARNINGS": "Liver warning : This product contains acetaminophen. Severe liver damage may occur if the 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, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.", "DIRECTIONS": "do not give more than directed (see overdose warning) shake well before use this product does not contain directions or complete warning for adult dose use only with enclosed dosing cup repeat dose every 4 hours while symptoms last find right dose on chart below. If possible, use weight to dose; otherwise, use age. mL = milliliter Weight (lb) Age (yr) Dose (mL) under 24 lbs under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL", "DO NOT USE": "with any other product containing acetaminophen (prescription or non-prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. if your child is allergic to acetaminophen or any of the inactive ingredients in this product.", "OTHER INFORMATION": "store between 20-25ºC (68-77ºF)", "ACTIVE INGREDIENT(S)": "Acetaminophen 160mg", "INACTIVE INGREDIENTS": "butylparaben, citric acid, flavor, glycerin, maltitol, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sucralose, Xanthan gum.", "QUESTIONS OR COMMENTS?": "Call 1-609-860-2600 (Monday - Friday 8 am - 4 pm)", "PRINCIPAL DISPLAY PANEL": "FAMILY Wellness TM COMPARE TO THE ACTIVE INGREDIENT IN CHILDRENS TYLENOL® LIQUID* children's PAIN RELIEVEER AGE 2 - 11 YEARS ACETAMINOPHEN 160 mg per 5 mL Oral Suspension Liquid PAIN RELIEVER/FEVER REDUCER Alcohol Free Aspirin Free Ibuprofen Free DYE-FREE CHERRY FLAVOR 4 FL OZ (118 mL) ", "WHEN USING THIS PRODUCT": "do not exceed recommended dose (see overdose warning)", "STOP USE AND ASK DOCTOR IF": "pain gets worse or last 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. Quick medical attention is critical even if you do not notice any signs or symptoms.", "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."}

Family Wellness Childrens Pain Reliever 574

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information