PAIN RELIEF INFANTS- acetaminophen suspension

Pain Relief by

Drug Labeling and Warnings

Pain Relief by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily reduces fever
• temporarily 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 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.

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.

When using this product,

do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days

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 (1-800-222-1222) right away. Quick 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 take more than directed (see overdose warning)
• shake well before using
• mL=milliliter
• only use the enclosd syringe.

Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.

• remove cap and insert syringe into hole at top of bottle and turn upside down.
• pull back syringe until filled to the prescribed level. if you pass the prescribed level, simply push syringe back until you have reached the desired level.Slowly dispense the liquid into your child's mouth (towards inner cheek).
• if needed, repeat dose every 4 hours while symptoms last.
• do not use give more than 5 times in 24 hours
• do not give more than 5 days unless directed by a doctor
• replace cap tightly to maintain child resistance
• find the right dose on chart below. If possible, use weight to dose; otherwise, use age.

Weight (lb)	Age (year)	Dose (mL)*
under 24	under 2	ask a doctor
24-35	2-3	5 mL

*or as directed by a doctor

Other information

• store between 20-25ºC (68-77ºF)
• do not refrigerate.
• see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, D&C red #33, FD&C blue #1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Infants' Tylenol® Oral Suspension**

Infants' Pain Relief

Acetaminophen 160 mg per 5 mL

oral suspension

pain reliever / fever reducer

for ages 2-3 years

alcohol free

aspirin free

ibuprofen free

FL OZ (mL)

Use Only Enclosed Syringe

Grape flavor

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Infants' Tylenol® Oral Suspension.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR PRINTED SAFETY SEAL AROUND BOTTLE IS BROKEN OR MISSING.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

Package Label

ReadyinCase Infants' Pain Relief Grape Liquid

INGREDIENTS AND APPEARANCE

PAIN RELIEF  INFANTS
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49580-0324
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)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49580-0324-2	1 in 1 BOX	04/30/2016
1		59 mL in 1 BOTTLE, PLASTIC; 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	04/30/2016

Labeler - P & L Development, LLC (101896231)