CVS POMEGRANATE COUGH- menthol lozenge
CVS Pharmacy, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CVS Pomegranate Cough Drops

Active Ingredients

Menthol 4.0 mg

Purpose

Cough suppressant/Oral anesthetic

Uses

temporarily relieves:

cough associated 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 such as occurs with smoking, asthma, or emphysema
cough accompanied by excessive phlegm (mucus)

When using this product

do not exceed recommended dosage

Stop Use and ask a doctor if

cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
sore throat is severe, or irritation, pain or redness lasts or worsens
sore mouth does not improve in 7 days

If pregnant or breast-feeding,

ask a health professional before use.

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

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 5 years and over: allow 2 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.

Children under 5 years: ask a doctor

Other information

10 calories per drop

Inactive ingredients

Citric acid, glucose syrup, natural flavoring, pomegranate juice concentrate, sucrose and water. Soybean oil used as processing aid.

Questions?

Or to report an adverse event call 1-800-245-2898. Monday through Friday, 9AM - 4PM EST.

Package Label

CVS pharmacy

GLUTEN FREE

Pomegranate

Cough Drops

Menthol Cough suppressant/Oral anesthetic

Temporarily relieves cough

& soothes sore throat pain

30 LOZENGES

Pomegranate Flavor

DISTRIBUTED BY:

CVS Pharmacy, Inc.

One Cvs Drive Woonsocket, RI 02895

2014 CVS/Pharmacy

CVS.com 1-800-SHOP CVS

Made in the USA

Front

Back

CVS POMEGRANATE COUGH
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-312
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 mg

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
POMEGRANATE JUICE (UNII: 99S671U9KB)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
SOYBEAN OIL (UNII: 241ATL177A)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	17mm
Flavor	POMEGRANATE	Imprint Code	B
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-312-30	30 in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/25/2015	01/18/2016

Labeler - CVS Pharmacy, Inc. (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
Bestco, Inc.		002149136	manufacture(59779-312)

Revised: 1/2016

Document Id: 29a1893d-388e-5bad-e054-00144ff8d46c

Set id: 98d78fa7-d58a-4aad-a043-ec71029de67f

Version: 2

Effective Time: 20160118

CVS Pharmacy, Inc.