COUGH DROPS- menthol tablet, orally disintegrating

Cough Drops by

Drug Labeling and Warnings

Cough Drops by is a Otc medication manufactured, distributed, or labeled by Xinsanyang Pharmaceutical (Xiamen) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Cough Drops

ACTIVE INGREDIENT

Menthol

PURPOSE

cough suppressant, oral anesthetic

INDICATIONS & USAGE

temporarily relieves: cough due to cold, occasional minor irritation or sore throat

WARNINGS

Sore throat warning: lf sore throat is severe, persists for more than 2 days, isaccompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctorprompfly. These may be serious.

DO NOT USE

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).

Stop use and ask a doctor if: cough persists for more than 1 week, tends to recur,
or is accompained 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.

WHEN USING

adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed.

children under 5 years: ask a doctor.

STOP USE

Stop use and ask a doctor if: cough persists for more than 1 week, tends to recur,
or is accompained 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed.

children under 5 years: ask a doctor.

STORAGE AND HANDLING

Dry, avoid sunlight

INACTIVE INGREDIENT

EUCALYPTUS OIL
FD&C BLUE NO. 1
FD&C RED NO. 40
POTASSIUM CITRATE
SOY LECITHIN
SUCRALOSE
SUCROSE
GLUCOSE SYRUP
CITRIC ACID
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COUGH DROPS 
menthol tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80404-501
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.4 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CORN SYRUP (UNII: 9G5L16BK6N)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	blue	Score	score with uneven pieces
Shape	OVAL	Size	20mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80404-501-01	25 in 1 BAG; Type 0: Not a Combination Product	06/29/2023
2	NDC: 80404-501-02	30 in 1 BAG; Type 0: Not a Combination Product	06/29/2023
3	NDC: 80404-501-03	70 in 1 BAG; Type 0: Not a Combination Product	06/29/2023
4	NDC: 80404-501-04	80 in 1 BAG; Type 0: Not a Combination Product	06/29/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/29/2023

Labeler - Xinsanyang Pharmaceutical (Xiamen) Co., Ltd. (546457554)

Establishment
Name	Address	ID/FEI	Business Operations
Xinsanyang Pharmaceutical (Xiamen) Co., Ltd.		546457554	manufacture(80404-501)