PHYSICIANS CARE COUGH AND SORE THROAT- menthol lozenge

Physicians Care Cough and Sore Throat by

Drug Labeling and Warnings

Physicians Care Cough and Sore Throat by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each lozenge)

Menthol 7.6 mg

Purpose

Antitussive (cough suppressant)/oral anesthetic

Uses

Temporarily relieves

■ cough as may occur with a cold or inhaled irritants

■ occasional minor irritation and sore throat

Warnings

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. These symptoms may be serious.

Ask a doctor before use if you have

■ persistent or chronic cough occurs with smoking, asthma, or emphysema

■ cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

■ cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent
headache. These could be signs of a serious condition.

■ sore mouth does not improve in 7 days

■ irritation, pain, or redness persists or worsens

If pregnant or breast feeding,

ask a health professional before use.

Keep this and all drugs out of the reach of children.

Directions

■ do not use more than directed

Adults and children: (12 years and older)

Allow 1 lozenge to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

■ 15 calories per lozenge

■ store at 59º-86ºF (15º-30ºC)

■ protect from moisture & heat

Inactive ingredients

cherry flavor, corn syrup, eucalyptus oil, FD&C red #40, sucrose

Questions?

1-800-835-2263

Physicians Care Cough and Sore Throat Label

90306

Physicians Care®

Cough and Sore Throat

Cherry/Eucalyptus Flavor Menthol Lozenges

Pull To Open

Individually Wrapped Lozenges

Menthol 7.6 mg/lozenge

50 Lozenges

INGREDIENTS AND APPEARANCE

PHYSICIANS CARE COUGH AND SORE THROAT 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0150
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7.6 mg

Inactive Ingredients
Ingredient Name	Strength
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
EUCALYPTUS OIL (UNII: 2R04ONI662)
SUCROSE (UNII: C151H8M554)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	22mm
Flavor	CHERRY	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0150-01	50 in 1 CARTON	01/05/2015
1		1 in 1 CELLO PACK; Type 0: Not a Combination Product
2	NDC: 0924-0150-02	125 in 1 CARTON	01/05/2015
2		1 in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/05/2015

Labeler - Acme United Corporation (001180207)

Registrant - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaloz		067101998	manufacture(0924-0150)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		170837962	relabel(0924-0150) , repack(0924-0150)