APAP ELIXER (ACETAMINOPHEN)- acetaminophen elixir

APAP ELIXER (ACETAMINOPHEN) by

Drug Labeling and Warnings

APAP ELIXER (ACETAMINOPHEN) by is a Otc medication manufactured, distributed, or labeled by GERITREX LLC. 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

To reduce fever and for the temporary relief of minor aches and pains due to:

• headache
• muscular aches
• backache
• minor pain of arthritis
• the common cold
• toothache
• premenstrual and menstrual cramps.

Temporarily reduces fever.

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if

• adult takes more than 6 doses in 24 hours, which is the maximum daily amount
• child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other
  drugs containing acetaminophen
• adult has 3 or more alcoholic drinks everyday while using
  this product.

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
• is on a sodium-restricted diet.

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

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.

If pregnant or breast-feeding, ask a health professional before use.

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/children even if you do not notice any signs or symptoms.

Directions

• shake well before using
• find the right dose on chart below, if possible, use weight to dose; otherwise use age
• dosage may be repeated every 4 hours, or as directed by your doctor
• do not use more than 5 doses in 24 hours
• do not use more than 5 days unless directed by a doctor.

Weight (lbs.)	Age (years)	dosage-teaspoonful (tsp.)
under 24	under 2	consult Physician
24-35	2 to 3	1 tsp. (5 mL)
36-47	4 to 5	1 1/2 tsp. (7.5 mL)
48-59	6 to 8	2 tsp. (10 mL)
60-71	9 to 10	2 1/2 tsp. (12.5 mL)
72-95	11 to 12	3 tsp. (15 mL)
over 95	12 to adult	4 tsp. (20 mL)

Other information

• Store at room temperature 15º-30ºC (59º-86ºF)
• protect from freezing
• protect from light
• each teaspoon (5mL) contains: sodium 7 mg

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Inactive Ingredients:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

APAP ELIXER (ACETAMINOPHEN) 
acetaminophen elixir

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-129
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY (CHERRY)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-129-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	08/20/2018

Labeler - GERITREX LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
GERITREX LLC		112796248	manufacture(54162-129)