BETTER LIVING BRANDS CHILDRENS FEVER AND PAIN RELIVER- acetaminophen suspension

better living brands childrens fever and pain reliver by

Drug Labeling and Warnings

better living brands childrens fever and pain reliver by is a Otc medication manufactured, distributed, or labeled by BETTER LIVING BRANDS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (per 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily:

• reduces fever
• relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.

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, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.

Ask a doctor before use if your child has

liver disease

Ask a doctor or pharmacist before use if the child is

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

• new symptoms occur
• pain gets worse or lasts more than 3 days
• fever gets worse or lasts more than 5 days
• 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) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

• This product does not contain directions or complete warnings for adult use
• Do not give more than directed (see overdose warning).
• Shake well before using
• Find right dose on chart below. (If possible, use weight to determine dosing; otherwise, use age.)
• Pour liquid into dosing cup to the appropriate amount for your child’s weight and/or age.
• Only use with enclosed dosing cup.
• If needed, repeat dose every 4 hours while symptoms last.
• Do not give more than 5 times in any 24-hour period (see overdose warning).
• Do not give more than 5 days unless directed by a doctor.
• Replace cap tightly to maintain child resistance.

Weight (lbs)	Age (yrs)	Dose
under 24	under 2	Ask a doctor
24-35	2- under 4	5 mL
36-47	4- under 6	7.5 mL
48-59	6- under 9	10 mL
60-71	9- under 11	12.5 mL
72-95	11- under 12	15 mL

Other information

• Store at room temperature
• Check expiration date on bottle or box before using
• DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

Inactive ingredients

citric acid, glycerin, natural flavor, potassium sorbate, povidone, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or comments?

1-866-467-2748

Principal Display Panel

NDC: 21130-746-04

Compare to the active ingredient in Little Remedies® Children’s Fever + Pain Reliever*

Children’s Fever + Pain Reliever

Acetaminophen 160 mg/ 5mL Pain reliever and Fever reducer

• Paraben Free
• Dye Free
• Gluten Free
• No Artificial Color
• No Aspirin or lbuprofen
• No High Fructose Corn Syrup

For Age 2-11

Natural Grape Flavor

4 FL. OZ. (118 mL)

DISTRIBUTED BY:

Lucerne North America LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by Prestige Consumer trademark Little Remedies® Children’s Fever + Pain Reliever.

INGREDIENTS AND APPEARANCE

BETTER LIVING BRANDS CHILDRENS FEVER AND PAIN RELIVER 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-746
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-746-04	1 in 1 CARTON	04/02/2019
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 not final	part343	04/02/2019

Labeler - BETTER LIVING BRANDS LLC (009137209)