CHILDRENS ACETAMINOPHEN - acetaminophen elixir
Rij Pharmaceutical Corporation

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

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
- immunizations
- 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

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 right away. 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
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
if needed, repeat dose every 4 hours
do not give more than 5 times in 24 hours
do not give more than 5 days unless directed by a doctor
only use enclosed measuring cup

Weight (lbs.)	Age (yrs.)	Dose (tsp or mL)
under 24	under 2	ask a doctor
24-35	2-3 years	1 tsp or 5 mL
36-47	4-5 years	1½ tsp or 7.5 mL
48-59	6-8 years	2 tsp or 10 mL
60-71	9-10 years	2½ tsp or 12.5 mL
72-95	11 years	3 tsp or 15 mL

Other information

•: Store at room temperature 15º - 30ºC (59º - 86ºF)
•: Protect from Freezing.
•: Protect from Light.
•: each teaspoon (5 mL) contains: sodium 7 mg
•: TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Inactive ingredients

citric acid, FD&C red # 40, FD&C blue # 1, flavor, glycerin. PEG 400, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.

PRINCIPAL DISPLAY PANEL

CHILDRENS ACETAMINOPHEN
acetaminophen elixir

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	53807-196
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (acetaminophen)	Acetaminophen	160 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
FD&C BLUE NO. 1
GLYCERIN
POLYETHYLENE GLYCOL 400
SODIUM BENZOATE
SODIUM CITRATE
SACCHARIN SODIUM
SORBITOL
WATER

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE (GRAPE)	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	53807-196-04	118 mL In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	03/16/1999

Labeler - Rij Pharmaceutical Corporation (144679156)

Revised: 04/2013Rij Pharmaceutical Corporation