FDA.reportPublic FDA data

WinCo 44-692-Delisted

Manufacturer
WinCo Foods, LLC | LNK International, Inc.
Effective date
2026-06-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-07-17 21:35:12

Label at a glance#

ProductCold and Flu HBP
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE
Label structure9 sections

Indications and uses

temporarily relieves: headache sneezing runny nose minor aches and pains sore throat temporarily reduces fever

Dosage and administration

do not take more than directed adults and children 12 years and over 2 tablets every 4 to 6 hours; do not take more than 12 tablets in 24 hours children 6 to under 12 years 1 tablet every 4 to 6 hours; do not take more than 5 tablets in 24 hours children under 6 years do not use unless directed by a doctor

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves:
    • headache
    • sneezing
    • runny nose
    • minor aches and pains
    • sore throat
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

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

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • to make a child sleepy

Ask a doctor before use if the user has

OTC - ASK DOCTOR SECTION

  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if the user is

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
  • avoid alcoholic beverages

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults)
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 take more than directed
adults and children 12 years and over2 tablets every 4 to 6 hours; do not take more than 12 tablets in 24 hours
children 6 to under 12 years1 tablet every 4 to 6 hours; do not take more than 5 tablets in 24 hours
children under 6 yearsdo not use unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, crospovidone, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call 1-800-824-1706 Monday – Friday 9am – 4pm MST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredients in CORICIDIN® HBP Cold & Flu

WinCo®
FOODS

Cold & Flu HBP

ACETAMINOPHEN 325 mg/
PAIN RELIEVER/FEVER REDUCER
CHLORPHENIRAMINE MALEATE 2 mg/
ANTIHISTAMINE

Relieves Runny Nose, Sneezing, Body Aches
and Pains, Fever, and Sore Throat

For People with High Blood Pressure

20
Tablets

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

*This product is not manufactured or
distributed by BAYER HEALTHCARE LLC,
distributor of CORICIDIN® HBP Cold & Flu.

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

100% SATISFACTION GUARANTEE

Comments & Questions? www.wincofoods.com

WinCo 44-692
WinCo 44-692

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67091-42667091-426-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-08-11full-release2026-06-01 01:11:02

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
ecee51ba-e314-4710-913f-9100219da8cef8c1f2b7-8b1b-49f2-a774-b3a38d31b10e2026-06-22WarningsExact identifier
spl id: ecee51ba-e314-4710-913f-9100219da8ce
spl set id: f8c1f2b7-8b1b-49f2-a774-b3a38d31b10e

Reported adverse events (FAERS/openFDA)#

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