FAMILY WELLNESS CHILDRENS PAIN RELIEVER 574- acetaminophen suspension

Family Wellness Childrens Pain Reliever 574 by

Drug Labeling and Warnings

Family Wellness Childrens Pain Reliever 574 by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services, Inc., Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Acetaminophen 160mg

PURPOSE

Pain reliever/fever reducer

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.

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.

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.

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.

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

OTHER INFORMATION

store between 20-25ºC (68-77ºF)

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 WellnessTM

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)

 

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS CHILDRENS PAIN RELIEVER 574 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-930
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-930-03	1 in 1 CARTON	04/18/2024
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	part343	04/18/2024

Labeler - Family Dollar Services, Inc. (024472631)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(55319-930)