FDA.reportPublic FDA data

PAIN RELIEF

Manufacturer
GERI-CARE PHARMACEUTICAL CORP
Effective date
2019-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:50:24

Label at a glance#

ProductPAIN RELIEF
Active ingredientACETAMINOPHEN
Label structure8 sections

Indications and 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.

Dosage and administration

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 ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (per teaspoonful = 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Liver warning:

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the user

  • has a liver disease
  • is on a sodium restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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 24under 2consult physician
24-352-31 tsp (5 mL)
36-474-51½ tsp (7.5 mL)
48-596-82 tsp (10 mL)
60-719-102½ tsp (12.5 mL)
72-95113 tsp or (15 mL)
over 9512 to adult4 tsp (20 mL)

Other information

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

180-16180-16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-180-16ML - Milliliter57896-180b7e6dcce-c275-4e74-b3c1-cf771553739b12018-06-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-18057896-180-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
ACETAMINOPHEN362O9ITL9DACTIB
SODIUM CITRATE1Q73Q2JULRIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cecbda4d-b0c3-8424-e053-2a95a90a472d6bc9fca3-0860-5363-e053-2991aa0a84d02021-10-20WarningsExact identifier
spl set id: 6bc9fca3-0860-5363-e053-2991aa0a84d0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.