LLORENS CARE CHILDREN ACETAMINOPHEN- acetaminophen suspension

Llorens Care Children Acetaminophen by

Drug Labeling and Warnings

Llorens Care Children Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Llorens Pharmaceutical International Division, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5mL = 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain Reliever / Fever Reducer

INDICATIONS & USAGE

Uses

• temporarily reduces fever
• temporarilty relieves minor aches and pains due to:
• headache
• sore throat
• the common cold
• 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 sever 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.

Do not use

• with any other drug containing acetaminophen (prescription or non-prescription). 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.

When using this product: Do not exceed recommended dose.

Ask a doctor before use if your child hasliver disease.

Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin.

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

Directions

• do not give more than directed
• shake well before using
• this product does not contain directions or complete warnings for adult use
• find dose in chart below; if possible, use weight to dose, otherwise use age
• dosage may be repeated every 4 hours, or as directed by a doctor
• do not give more than 5 times in 24 hours

Weight (lbs)	under 24	24-35	36-47	48-59	60-71	72-95	over 95
Age (years)	under 2	2 to 3	4 to 5	6 to 8	9 to 10	11	12 to adult
Dosage Teaspoonful (tsp)	consult physician	1 tsp (5 mL)	1 1/2 tsp (7.5 mL)	2 tsp (10 mL)	2 1/2 tsp (12.5 mL)	3 tsp (15 mL)	4 tsp (20 (mL)

Inactive ingredients

artifical and natural grap flavor, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium, potassium sorbate, purified water, sorbitol solution, sucralose, and xanthan gum

QUESTIONS? COMMENTS?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LLORENS CARE CHILDREN ACETAMINOPHEN 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-850
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
SUCROSE (UNII: C151H8M554)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-850-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2024
2	NDC: 54859-850-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	12/01/2024

Labeler - Llorens Pharmaceutical International Division, Inc. (037342305)