KOSHER MEDS CHILDRENS PAIN AND FEVER- acetaminophen suspension

KOSHER MEDS Childrens Pain and Fever by

Drug Labeling and Warnings

KOSHER MEDS Childrens Pain and Fever by is a Otc medication manufactured, distributed, or labeled by Mollec Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

(in each 5 mL = 1 teaspoonful)
Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

temporarily ■ reduces fever
■ relieves minor aches and pains due to:
■ the common cold ■ flu ■ headache ■ sore throat
■ 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, 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 DOCTOR

Ask a doctor before use if your child hasliver disease

ASK DOCTOR/PHARMACIST

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

When using this product

do not exceed recommended dose (see overdose warning)

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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• ​this product does not contain directions or complete warnings for adult use
• shake well before using
• mL = milliliter; tsp = teaspoonful
• find right dose on chart below. If possible, use weight to dose; otherwise use age.
• if needed, repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• do not give for more than 5 days unless directed by a doctor.

Dosing Chart

Weight (lb)	Age (yr)	Dose (mL or tsp)*
under 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL  (1 tsp)
36-47 lbs	4-5 years	7.5 mL  (1 1⁄2 tsp)
48-59 lbs	6-8 years	10 mL   (2 tsp)
60-71 lbs	9-10 years	12.5 mL  (2 1⁄2 tsp)
72-95 lbs	11 years	15 mL  (3 tsp)

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically
designed for use with this product. Do not use any
other dosing device.

Other information

• Keep carton for full directions for use
• each 5 mL (1 tsp) contains: sodium 3 mg
• store between 20-25°C (68-77°F)
• do not refrigerate

Inactive ingredients

anhydrous citric acid, butylparaben, FD&C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and
carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Product label

INGREDIENTS AND APPEARANCE

KOSHER MEDS CHILDRENS PAIN AND FEVER 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82179-002
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)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82179-002-04	1 in 1 CARTON	01/18/2023
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	M013	01/18/2023

Labeler - Mollec Inc (040088196)