Herbal Cough Drops: Package Insert and Label Information

HERBAL COUGH DROPS- menthol lozenge
Walmart

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 4.8 mg

Purpose

Cough suppressant / Oral anesthetic

Uses temporarily relieves:

cough as may occur with a cold or inhaled irritants

minor 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 worsens
  • 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 6 years and over — allow 2 drops to dissolve slowly in mouth, one at a time. May be repeated every 2 hours as necessary or as directed by a doctor.

children under 6 years — ask a doctor

Other information

  • 17 calories per drop

Inactive ingredients: Caramel (color), corn starch, glucose syrup, herbal extract blend (Elderflower, Horehound, Hyssop, Lemon Balm, Linden Flower, Marshmallow Root, Peppermint, Sage, Thyme, Wild Thyme), medium chain triglycerides, natural flavors, soybean oil, sucrose, and water.

Questions? 1-888-287-1915.

Equate Herbal 50ct Cough Drops
(click image for full-size original)

HERBAL COUGH DROPS
menthol lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-031
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 4.8 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE
Product Characteristics
Color brown Score no score
Shape OVAL Size 17mm
Flavor MENTHOL (Menthol & Herbal Blend) Imprint Code B
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49035-031-50 50 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 02/08/2018
Labeler — Walmart (051957769)
Registrant — Bestco Inc. (002149136)
Establishment
Name Address ID/FEI Operations
Bestco Inc. 002149136 manufacture (49035-031)

Revised: 01/2020 Walmart

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