Aramark

Aramark
SPL v2
SPL
SPL Set ID 478efdb0-8fb7-40a6-991f-dfe60b76e622
Route
ORAL
Published
Effective Date 2021-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5.8 mg)
Inactive Ingredients
Starch, Corn Corn Syrup Eucalyptus Oil Fd&c Red No. 40 Glycerin Medium-chain Triglycerides Soybean Oil Sucrose Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-02-26

Description

Drug Facts


Medication Information

Warnings and Precautions

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. If sore mouth

symptoms do not improve in 7 days, see your

dentist or doctor promptly. These symptoms

may be serious.

Indications and Usage

Uses:

Temporarily Relieves:

■ Cough as may occur with a cold Occasional

   minor irritation and sore throat

Dosage and Administration

Directions

 Adults and

children:

(5 years

and older)
 Allow 1 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.

Description

Drug Facts

aramark

Cherry Cough Drops

Menthol / Mentol 5.8mg

Cough Suppressant &

Anesthetic with Vapor Action

Individually Wrapped Cough Drops

50 TABLETS         Part # 582R23

PER BOX

Compare active ingredient to:

HALLS®

Registered Trademark of Warner-Lambert

MANUFACTURED FOR:

Aramark

Lenexa, KS 66219

(913) 269-9611

Retain carton for complete product information

50 Cough Drop Package

125 Cough Drop Package

res

Section 42228-7

If pregnant or breast-feeding, ask a health

professional before use.

Section 42229-5

Drug Facts

Section 50565-1

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

of accidental overdose, get medical help or

contact a Poison Control Center right away

Section 50566-9

Stop use and consult 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, pan or

  redness lasts. These could be signs of a

  serious condition.

■ Sore mouth does not improve in 7 days.

Section 50567-7

When using this product:

■ Do not exceed recommended dosage

Section 50569-3

Ask a doctor before use if you have:

■ Persistent cough or chronic cough such as

  occurs with smoking, asthma, or emphysema

■ Cough accompanied by excessive phlegm

  (mucus)

Section 51727-6

Inactive ingredients:

Corn Starch, corn syrup, eucalyptus oil,

FD&C red no. 40, glycerin, medium chain

triglycerides, natural & artificial flavors,

soybean oil, sucrose and water.

Section 55105-1

Purpose

Cough Suppressant/Oral Anesthetic

Section 55106-9

Active Ingredient (in each drop)

Menthol 5.8 mg

Section 60561-8

Other information 10-calories per drop

Tamper Evident: Do not use if bag/pouch is

torn or open.


Structured Label Content

aramark

Cherry Cough Drops

Menthol / Mentol 5.8mg

Cough Suppressant &

Anesthetic with Vapor Action

Individually Wrapped Cough Drops

50 TABLETS         Part # 582R23

PER BOX

Compare active ingredient to:

HALLS®

Registered Trademark of Warner-Lambert

MANUFACTURED FOR:

Aramark

Lenexa, KS 66219

(913) 269-9611

Retain carton for complete product information

50 Cough Drop Package

125 Cough Drop Package

res

Indications and Usage (34067-9)

Uses:

Temporarily Relieves:

■ Cough as may occur with a cold Occasional

   minor irritation and sore throat

Dosage and Administration (34068-7)

Directions

 Adults and

children:

(5 years

and older)
 Allow 1 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.

Warnings and Precautions (34071-1)

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. If sore mouth

symptoms do not improve in 7 days, see your

dentist or doctor promptly. These symptoms

may be serious.

Section 42228-7 (42228-7)

If pregnant or breast-feeding, ask a health

professional before use.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

of accidental overdose, get medical help or

contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and consult 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, pan or

  redness lasts. These could be signs of a

  serious condition.

■ Sore mouth does not improve in 7 days.

Section 50567-7 (50567-7)

When using this product:

■ Do not exceed recommended dosage

Section 50569-3 (50569-3)

Ask a doctor before use if you have:

■ Persistent cough or chronic cough such as

  occurs with smoking, asthma, or emphysema

■ Cough accompanied by excessive phlegm

  (mucus)

Section 51727-6 (51727-6)

Inactive ingredients:

Corn Starch, corn syrup, eucalyptus oil,

FD&C red no. 40, glycerin, medium chain

triglycerides, natural & artificial flavors,

soybean oil, sucrose and water.

Section 55105-1 (55105-1)

Purpose

Cough Suppressant/Oral Anesthetic

Section 55106-9 (55106-9)

Active Ingredient (in each drop)

Menthol 5.8 mg

Section 60561-8 (60561-8)

Other information 10-calories per drop

Tamper Evident: Do not use if bag/pouch is

torn or open.


Advanced Ingredient Data


Raw Label Data

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