FDA.reportPublic FDA data

Regular Strength Pain Relief

Manufacturer
REMEDYREPACK INC.
Effective date
2022-03-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:06:07

Label at a glance#

ProductRegular Strength Pain Relief
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains temporarily reduces fever

Dosage and administration

do not take more than directed adults and children 12 years and over: take 2 tablets every 4-6 hours, as needed; not more than 10 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor. children under 12 years: ask a doctor

Storage and handling

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken. store at 20⁰C-25⁰C (68⁰F-77⁰F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:

  • more than 12 tablets (4,000 mg of acetaminophen)

in 24 hours

  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using

this product
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.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptom 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • adults and children 12 years and over: take 2 tablets every 4-6 hours, as needed; not more than 10 tablets in 24 hours. Do not take
    for more than 10 days unless directed by a doctor.
  • children under 12 years: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

povidone, sodium starch glycolate, starch stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Regular Strength Pain Relief

GENERIC: Acetaminophen

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-1855-0

NDC: 70518-1855-1

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: GC101

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ACETAMINOPHEN 325mg in 1

INACTIVE INGREDIENT(S):

  • POVIDONE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
  • STARCH, CORN
  • STEARIC ACID

Remedy_LabelRemedy_Label

MM2MM2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-1855-1EA - Each70518-18556dd8086a-7ef0-4e32-b3ca-4419ee17442612023-01-09
57896-102-01EA - Each57896-1024fd0e2b7-fd19-4784-9e24-f0fc69b7491012019-01-24
57896-102-05EA - Each57896-102b63010e7-a608-44c2-b043-44d6f2818c5912019-02-13
57896-102-10EA - Each57896-1026b3d573d-baa1-4daf-aba9-717aa1dcfc7412019-02-13
57896-102-20EA - Each57896-10240b6eab0-c1a1-4c63-82f8-78251de158a212021-12-08

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-185570518-1855-0, 70518-1855-1
57896-102

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corp6158e954-32d8-4718-e053-2a91aa0a27f32024-12-31WarningsExact identifier
ndc (product): 57896-102
ea7354a9-371a-2f01-e053-2995a90a7787da36e6fa-e041-47f2-ba52-7ed865ddad102022-10-07WarningsExact identifier
spl set id: da36e6fa-e041-47f2-ba52-7ed865ddad10

Reported adverse events (FAERS/openFDA)#

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