LITTLE REMEDIES INFANT FEVER/PAIN RELIEVER NATURAL GRAPE NATURAL GRAPE- acetaminophen liquid

Little Remedies Infant Fever/Pain Reliever Natural Grape by

Drug Labeling and Warnings

Little Remedies Infant Fever/Pain Reliever Natural Grape by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

• Active Ingredient: Purpose
• Acetaminophen 160mg: Pain Reliever/Fever Reducer

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 reddining
• Blisters
• Rash
• If 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.

Ask a doctor before use

If your child has liver disease.

Ask a doctoror pharmacist before use

If your child is taking the blood thinning drug warfarin.

Do not use:

• With any other products 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 DOSAGE (see overdose warning).

Stop use and ask a doctor if:

• New symptoms occur.
• Fever gets worse or lasts more than 3 days.
• Pain 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.

OverdoseWarning:

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 of 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 the right dose on side panel. (If possible, use weight to determine dose; otherwise, use age.)
• Only use with enclosed AccuSafe ® syringe
• Remove cap, insert syringe to flow restrictor and invert bottle
• Pull back syringe until filled to the prescribed level and slowly dispense the liquid into your child's mouth (towards the inner cheek)
• If needed, repeat dose every 4 hours while symptoms last.
• Do not give more than 5 days in any 24-hour period
• Replace cap tightly to maintain child resistance. mL = mililiter

Weight (lb)	Age (yr)	Dose
Under 24	Under 2	Ask a doctor
24-35	2 – 3	5mL

Other Information

• Each 5 mL contains: sodium 6 mg
• Store at 20-25ºC (68-77ºF)
• AccuSafe ® Oral dosing device enclosed
• Check expiration date on bottle or box before using

Inactive Ingredients:

Benzoic acid, carboxymethylcellulose, glycerin, natural grape flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, xanthan gum

Questions?

For further information you may contact us at: 1-800-754-8853 Mon. – Fri. 8:00 a.m. to 8:00 p.m. EST, or visit us at www.LittleRemedies.com.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LITTLE REMEDIES INFANT FEVER/PAIN RELIEVER NATURAL GRAPE  NATURAL GRAPE
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9003
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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-9003-12	1 in 1 CARTON	04/18/2019
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0295-9003-17	1 in 1 CARTON	04/18/2019
2		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	04/18/2019

Labeler - Denison Pharmaceuticals, Inc. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, Inc.		001207208	manufacture(0295-9003)