FDA.reportPublic FDA data

MEDIQUE APAP Extra Strength

Manufacturer
Proficient Rx LP
Effective date
2024-02-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:08:53

Label at a glance#

ProductMEDIQUE APAP Extra Strength
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains associated with • headache • toothache • minor arthritis pain • muscular aches • common cold • menstrual cramps For the reduction of fever.

Dosage and administration

• do not use more than directed Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains associated with

  • headache
  • toothache
  • minor arthritis pain
  • muscular aches
  • common cold
  • menstrual cramps

For the reduction of fever.

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

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

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug
    contains acetaminophen, ask a doctor or pharmacist.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

OTC - STOP USE SECTION

  • symptoms do not improve
  • pain or fever persists or gets worse
  • new symptoms occur
  • redness or swelling is present
If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 use more than directed

Adults and children: (12 years and older)

SPL UNCLASSIFIED SECTION

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:

SPL UNCLASSIFIED SECTION

Do not give this adult strength product to children under 12 years of age;

this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized corn starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

* May contain

OTC - QUESTIONS SECTION

Questions or comments? 1-800-634-7680

XS APAP 500 mg Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength

APAP

Non-Aspirin Tablets

This Package is For Households Without Young Children

Pull to Open

Pain Reliever/Fever Reducer ● Acetaminophen 500mg

8 Tablets

(2 x 4)

Tamper Evident Unit Dose Packets

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

71205-461-08
71205-461-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN4
198440acetaminophen 500 MG Oral TabletSCD4
198440APAP 500 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-461-08MEDIQUE APAP Extra Strength4 in 1 BOXTABLET, FILM COATED44
71205-461-08MEDIQUE APAP Extra Strength2 in 1 PACKETTABLET, FILM COATED24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-461MEDIQUE APAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 2 package rows20240223_c466a07f-2339-4cf5-8377-e0f109649c52.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47682-175-13EA - Each47682-175c9f82a9e-9417-4f93-bb3a-27e3962ea6e812012-07-24
47682-175-33EA - Each47682-1757d5d8be4-afc5-487c-9350-face2a62666c12012-07-24
47682-175-48EA - Each47682-175321de510-dc8a-4f76-b96e-665741a7c5ef12012-07-24
47682-175-64EA - Each47682-1756a68a6a0-350a-4c84-8a44-4a08bbf3a81312012-07-24

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71205-46171205-461-08
47682-175

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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
MEDIQUE APAP Extra StrengthACETAMINOPHENUnifirst First Aid Corporation56822785-d5fb-4869-971e-5de637c2eda82025-09-08WarningsExact identifier
ndc (product): 47682-175
MEDIQUE APAP Extra StrengthACETAMINOPHENProficient Rx LPc466a07f-2339-4cf5-8377-e0f109649c522024-02-01WarningsExact identifier
ndc (package): 71205-461-08
ndc (product): 71205-461
ndc11 (package): 71205046108
spl id: c398d777-fd40-4ba7-94ab-0476bc8b5e44
spl set id: c466a07f-2339-4cf5-8377-e0f109649c52

Reported adverse events (FAERS/openFDA)#

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