PAIN RELIEF- acetaminophen suspension

PAIN RELIEF by

Drug Labeling and Warnings

PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by GERI-CARE PHARMACEUTICAL CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (per teaspoonful = 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/Fever reducer

Uses

Temporarily relieves 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
• adults has 3 or more alcoholic drinks everyday while using this product

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 you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if the user

• has a 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 breastfeeding, 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 even if you do not notice any signs or symptoms.

Directions

• find 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 a doctor
• do not use more than 5 times in 24 hours

Weight (lbs.)	Age (yrs.)	Dose (tsp or mL)
under 24	under 2	consult physician
24-35	2-3	1 tsp (5 mL)
36-47	4-5	1½ tsp (7.5 mL)
48-59	6-8	2 tsp (10 mL)
60-71	9-10	2½ tsp (12.5 mL)
72-95	11	3 tsp or (15 mL)
over 95	12 to adult	4 tsp (20 mL)

Other information

• each teaspoon (5 mL) contains: sodium 7 mg
• Store at room temperature 15º - 30ºC (59º - 86ºF)
• Protect from Freezing.
• Protect from Light.
• for institutional use only

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-180
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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-180-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2012	09/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	12/01/2012	09/30/2022

Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254)

Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)