Physicians Care Cold Cough

Manufacturer
Acme United Corporation
Effective date
2023-02-23
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:35:43

Label at a glance#

ProductPhysicians Care Cold Cough
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure11 sections

Indications and uses

Temporarily relieves these cold symptoms ■ cough ■ sore throat ■ minor aches and pains ■ headache ■ nasal congestion ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive Temporarily reduces fever.

Dosage and administration

Adults and children: (12 years and older) Take 2 tablets with water every 6- 8 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years Do not give to children under 12 years of age.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 15 mg

Guaifenesin 200 mg

Phenylephrine Hydrochloride 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/ fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these cold symptoms

■ cough

■ sore throat

■ minor aches and pains

■ headache

■ nasal congestion

■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Temporarily reduces fever.

Warnings

WARNINGS SECTION

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

■ more than 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.

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

■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression,
psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If
you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this
product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ liver disease

■ heart disease

■ high blood pressure

■ thyroid disease

■ diabetes

■ trouble urinating due to an enlarged prostate gland

■ cough that occurs with too much phlegm (mucus)

■ persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

■ taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ new symptoms occur

■ redness or swelling is present

■ pain or nasal congestion gets worse or lasts for more than 7 days

■ fever gets worse or lasts for more than 3 days

■ you get nervous, dizzy or sleepless

■ cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

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

Adults and children:

(12 years and older)

Take 2 tablets with water every 6- 8 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years

Do not give to children under 12 years of age.

Other information

OTHER SAFETY INFORMATION

■ store at room temperature 59º-86ºF (15º-30ºC)

■ avoid excessive heat and humidity

■ tamper evident sealed packets

■ do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide*, sodium starch glycolate, starch, stearic acid

Questions?

OTC - QUESTIONS SECTION

1-800-835-2263

Physicians Care Cold & Cough Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

90092

Physicians Care®

Non-Drowsy

Cold & Cough

Cold, Cough and Flu Relief

Pull To Open

TRhis Package For Households Without Young Children.

Do not use if packet is open or torn.

Tamper-Evident Packets of 2 Tablets

100 Tablets (50 Packets, 2 tablets each)

PC ColdCough Label 2PC ColdCough Label 2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-01410924-0141-01, 0924-0141-00, 0924-0141-03

Ingredients#

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

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

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
f55f6a03-08af-619d-e053-2995a90ab3074e2b6881-58ba-6963-e054-00144ff88e882023-02-23WarningsExact identifier
spl id: f55f6a03-08af-619d-e053-2995a90ab307
spl set id: 4e2b6881-58ba-6963-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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