Unishield Cherry Cough Drops

Unishield Cherry Cough Drops
SPL v5
SPL
SPL Set ID b8297bc1-44b2-3de0-e053-2995a90ad01b
Route
ORAL
Published
Effective Date 2021-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (7.6 mg)
Inactive Ingredients
Eucalyptus Oil Corn Syrup Fd&c Red No. 40 Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: oval Color: red Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01

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.

Indications and Usage

Uses

Temporarily relieves

  • cough as may occur with a cold or inhaled irritants
  • occasional minor irritation and sore throat
Dosage and Administration

Directions

  • do not use more than directed

Adults and children: (12 years and older)

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

Children under 12 years:

Ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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
Section 50569-3

Ask a doctor before use

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)
Section 51727-6

Inactive ingredients:

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

Section 51945-4

Unishield

Cough Drop

Cough Suppressant/Oral Anesthetic

50 Drops/Individually Wrapped

Cherry Flavored

Menthol 7.6 mg

Pull To Open

• Temporarily relieves sore throat and cough

• Pleasant tasting formula

• Menthol vapors ease congestion

Compare active ingredients to:

Hall®

Registered Trademark of Warner-Lambert

Individually Wrapped Cough Drops

Section 53414-9

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

Section 55105-1

Purpose

Antitussive (cough suppressant)/oral anesthetic

Section 55106-9

Active ingredient (in each drop)

Menthol 7.6 mg

Section 60561-8

Other information

  • 15 calories per drop
  • store at 59º-86ºF (15º-30ºC)
  • protect from moisture & heat

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves

  • cough as may occur with a cold or inhaled irritants
  • occasional minor irritation and sore throat
Dosage and Administration (34068-7)

Directions

  • do not use more than directed

Adults and children: (12 years and older)

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

Children under 12 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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 50569-3 (50569-3)

Ask a doctor before use

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)
Section 51727-6 (51727-6)

Inactive ingredients:

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

Section 51945-4 (51945-4)

Unishield

Cough Drop

Cough Suppressant/Oral Anesthetic

50 Drops/Individually Wrapped

Cherry Flavored

Menthol 7.6 mg

Pull To Open

• Temporarily relieves sore throat and cough

• Pleasant tasting formula

• Menthol vapors ease congestion

Compare active ingredients to:

Hall®

Registered Trademark of Warner-Lambert

Individually Wrapped Cough Drops

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antitussive (cough suppressant)/oral anesthetic

Section 55106-9 (55106-9)

Active ingredient (in each drop)

Menthol 7.6 mg

Section 60561-8 (60561-8)

Other information

  • 15 calories per drop
  • store at 59º-86ºF (15º-30ºC)
  • protect from moisture & heat

Advanced Ingredient Data


Raw Label Data

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