LITTLE REMEDIES INFANT FEVER AND PAIN RELIEVER NATURAL BERRY NATURAL BERRY- acetaminophen liquid

Little Remedies Infant Fever and Pain Reliever Natural Berry by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

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 skin reactions 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 doctor or 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.

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.

When using this product

DO NOT EXCEED RECOMMENDED DOSAGE; taking more than the recommended dose (overdose) may not provide more relief and may cause liver damage.

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.

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 (1-800-222-1222) immediately. 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.

• Shake well before using.
• Find the right dose on the chart below. (If possible, use weight to determine dose; otherwise, use age.)
• Only use the enclosed AccuSafe TM syringe.
• Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
• Remove cap, attach syringe to flow restrictor and invert bottle.
• Pull back syringe until filled to prescribed level and slowly dispense the liquid into your child’s mouth (toward the inner cheek).
• 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).
• Replace cap tightly to maintain child resistance.

Weight (lbs)	Age (yrs)	Dose
Under 24	Under 2	Ask a doctor
24-35	2-3	5.0 mL

Other information

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

Inactive ingredients

Benzoic acid, carboxymethylcellulose, glycerin, natural berry 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, www.LittleRemedies.com.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LITTLE REMEDIES INFANT FEVER AND PAIN RELIEVER NATURAL BERRY  NATURAL BERRY
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9002
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
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZOIC ACID (UNII: 8SKN0B0MIM)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SUCROSE (UNII: C151H8M554)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-9002-12	1 in 1 BOX	04/18/2019
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0295-9002-17	1 in 1 BOX	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(0295-9002)