PREMIER VALUE- cough drops menthol lozenge

Premier Value by

Drug Labeling and Warnings

Premier Value by is a Otc medication manufactured, distributed, or labeled by Xiamen Kang Zhongyuan Biotechnology Co., Ltd., Medical Group Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Menthol 5.4 mg

Purpose

Purposes cough suppressant, oral anesthetic

Use

temporary relieves: ■ cough due to cold ■ occasional minor irritation or sore throat

Warnings

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

ASK DOCTOR

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

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 serius 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.

Directions

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

■ children under 5 years: ask a doctor.

Other information

■ 10 calories per drop ■ contains: SOY.

Inactive ingredients

Glucose syrup, sucralose, citric acid, eucalyptus oil, FD&C blue 1, FD&C red 40, flavors, potassium citrate, sucrose, soy lecithin, water

QUESTIONS

Or, to report an adverse event, call 800-245-2898.
Monday - Friday, 9 AM to APM EST

Package Label - Principal Display Panel

30 Drops NDC: 61658-885-30

INGREDIENTS AND APPEARANCE

PREMIER VALUE 
cough drops menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83698-885
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
SUCROSE (UNII: C151H8M554)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CORN SYRUP (UNII: 9G5L16BK6N)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	score with uneven pieces
Shape	OVAL	Size	21mm
Flavor	MENTHOL	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83698-885-30	5.4 in 1 BAG; Type 0: Not a Combination Product	07/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/31/2023

Labeler - Xiamen Kang Zhongyuan Biotechnology Co., Ltd. (411759931)

Registrant - Medical Group Care LLC (085137089)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.		411759931	manufacture(83698-885)