PHYSICIANS CARE NON-DROWSY COLD AND COUGH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated

Physicians Care Non-Drowsy Cold and Cough by

Drug Labeling and Warnings

Physicians Care Non-Drowsy Cold and Cough by is a Otc medication manufactured, distributed, or labeled by Acme United, Unifirst First Aid Corportaion, Prestige Packaging, Medique Products, LNK International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active Ingredient

Active ingredient (in each caplet)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 10 mg

Guaifenesin 100 mg

Phenylephrine Hydrochloride 5 mg

Purpose

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

Uses

Temporarily relieves these cold symptoms

• cough
• sore throat
• minor aches and pains
• headache
• nasal congestion
• sinus congestion and pressure
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive

Temporarily reduces fever.

Warnings

Warnings

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

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.
• 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

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the 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 before use if you are taking the blood thinning drug warfarin.

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin.

When using this product do not exceed recommended dosage.

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if

Stop use and ask a doctor if

• new symptons occur
• redness or swelling is present
• pain, cough or nasal congestion gest worse or lasts for more than 7 days
• fever gets worse or lasts more than 3 days
• nervousness, dizziness, or sleeplessness occur
• cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Keep out of reach of children.

In case of 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

Directions

• do not take more than directed

​ Adults and children: (12 years and older)

Take 2 caplets every 4 hours
Do not to take more than 10 caplets in 24 hours

Children under 12 years: ask a doctor

Other information

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• tamper evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

Inactive ingredients

corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions

Questions? 1-800-835-2263

Physicians Care Cold & Cough

91462

PhysiciansCare®

Non-Drowsy

Cold & Cough

Cold, Cough and Flu Relief

Pull

to Open

COATED CAPLET

Individually packaged for workplace use

Tamper-Evident Packets of 2 Caplets

Do not use if packet is open or torn.

Not Actual Size

100 Caplets (50 Packets, 2 caplets each)

INGREDIENTS AND APPEARANCE

PHYSICIANS CARE NON-DROWSY COLD AND COUGH 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0142
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE ((Caplet))	Size	17mm
Flavor		Imprint Code	44;546
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0142-01	50 in 1 BOX	01/19/2023
1	NDC: 0924-0142-00	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/19/2023

Labeler - Acme United (001180207)

Registrant - Unifirst First Aid Corportaion (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		080667761	pack(0924-0142)

Establishment
Name	Address	ID/FEI	Business Operations
Medique Products		086911794	pack(0924-0142)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International		832867837	manufacture(0924-0142)