Family Wellness 44-006

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Anhydrous Citric Acid D&c Red No. 33 Fd&c Blue No. 1 Glycerin High Fructose Corn Syrup Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Water Sodium Benzoate Sorbitol Solution Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-11-26

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Uses

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

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
shake well before using
mL = milliliter
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

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.

Other Information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients

anhydrous citric acid, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

1-800-426-9391

Principal Display Panel

FAMILY

Wellness™

COMPARE TO THE

ACTIVE INGREDIENT

IN CHILDREN’S

TYLENOL® ORAL

SUSPENSION†

children's

PAIN

RELIEF

AGES

2-11

YEARS

ACETAMINOPHEN

160 mg per 5 mL

Oral Suspension

PAIN RELIEVER/FEVER REDUCER

• Alcohol Free

• Ibuprofen Free

• Aspirin Free

• Paraben Free

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 Kenvue Inc.,

owner of the registered trademark Children’s Tylenol® Oral

Suspension. 50844 ORG022400636

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

NOT 100% SATISFIED?

Return within 30 days to the

store of purchase for a refund

(with receipt) or exchange.

Family Wellness 44-006

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
redness or swelling is present
any new symptoms appear

Keep Out of Reach of Children.

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.

Active Ingredient (in Each 5 Ml)

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:
- headache
- sore throat
- flu
- toothache
- the common cold
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

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
shake well before using
mL = milliliter
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

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.

Other Information (Other information)

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

FAMILY

Wellness™

COMPARE TO THE

ACTIVE INGREDIENT

IN CHILDREN’S

TYLENOL® ORAL

SUSPENSION†

children's

PAIN

RELIEF

AGES

2-11

YEARS

ACETAMINOPHEN

160 mg per 5 mL

Oral Suspension

PAIN RELIEVER/FEVER REDUCER

• Alcohol Free

• Ibuprofen Free

• Aspirin Free

• Paraben Free

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 Kenvue Inc.,

owner of the registered trademark Children’s Tylenol® Oral

Suspension. 50844 ORG022400636

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

NOT 100% SATISFIED?

Return within 30 days to the

store of purchase for a refund

(with receipt) or exchange.

Family Wellness 44-006

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
redness or swelling is present
any new symptoms appear

Keep Out of Reach of Children. (Keep out of reach of children.)

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.

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

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: headache sore throat flu toothache the common cold 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 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 shake well before using mL = milliliter 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", "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.", "Other information": "store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number", "Inactive ingredients": "anhydrous citric acid, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum", "Questions or comments?": "1-800-426-9391", "Principal Display Panel": "FAMILY Wellness™ COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S TYLENOL® ORAL SUSPENSION† children's PAIN RELIEF AGES 2-11 YEARS ACETAMINOPHEN 160 mg per 5 mL Oral Suspension PAIN RELIEVER/FEVER REDUCER • Alcohol Free • Ibuprofen Free • Aspirin Free • Paraben Free 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 Kenvue Inc., owner of the registered trademark Children’s Tylenol® Oral Suspension. 50844 ORG022400636 DISTRIBUTED BY: MIDWOOD BRANDS, LLC 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA NOT 100% SATISFIED? Return within 30 days to the store of purchase for a refund (with receipt) or exchange. Family Wellness 44-006", "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 redness or swelling is present any new symptoms appear", "Keep out of reach of children.": "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.", "Active ingredient (in each 5 mL)": "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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information