Menthol Cough Drop: Package Insert and Label Information

MENTHOL COUGH DROP- menthol lozenge
Walgreens

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.

Active ingredient (in each drop)

Menthol 5.4 mg

Purpose

Cough suppressant/

Oral anesthetic

Uses temporarily relieves:

cough as may occur with a cold

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, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or 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)

Stop use and ask 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 wrosens
  • sore mouth does not improve in 7 days

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

Keep out of reach of children.

Directions

adults and children 5 years and over 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

Other information 10 calories per drop

Inactive ingredients: Corn starch, corn syrup, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, glycerin, gum arabic, medium chain triglycerides, natural flavors, potassium sorbate, soybean oil, sucrose and water.

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

Walgreens Menthol 200ct Cough Drops
(click image for full-size original)

MENTHOL COUGH DROP
menthol lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1084
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 5.4 mg
Inactive Ingredients
Ingredient Name Strength
WATER
Product Characteristics
Color blue (Light blue with flakes) Score score with uneven pieces
Shape OVAL Size 17mm
Flavor MENTHOL Imprint Code B
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-1084-00 200 LOZENGE in 1 BAG None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/05/2016
Labeler — Walgreens (008965063)
Registrant — BestCo Inc. (002149136)
Establishment
Name Address ID/FEI Operations
BestCo Inc. 002149136 manufacture (0363-1084)

Revised: 12/2021 Walgreens

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