Black Cherry Cough Drops: Package Insert and Label Information

BLACK CHERRY COUGH DROPS- menthol pastille
Boston Nutraceutical Production SL

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 Purposes

Menthol 5.8 mg Cough Suppressant

Oral anesthetic

Front label
(click image for full-size original)

Purposes

Cough suppressant/

Oral anesthetic

Uses Temporarily relieves:

  • cough as may occur with cold or inhaled irritants
  • ocassional minor irritations 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, swealing, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptons 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 excessvie phlegm (mucus)

Stop use and consult 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 last or worsens
  • sore mouth does not improve in 7 days

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

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

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

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

  • 6 calories per drop
  • May be useful for diabetics on the advise of a doctor
  • Excessive consumption may cause laxative effect

Citric acid, isomalt, stevia, flavor cherry extract, colorant black currant and black carrot extract, water

Back Label
(click image for full-size original)

Questions or comments call: 617-848-4560

Front

BLACK CHERRY COUGH DROPS
menthol pastille
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72628-104
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 5.8 mg
Inactive Ingredients
Ingredient Name Strength
BLACK CARROT
CHERRY
ISOMALT
WATER
ANHYDROUS CITRIC ACID
STEVIA REBAUDIANA WHOLE
BLACK CURRANT
Product Characteristics
Color red (Red- Dark red) Score score with uneven pieces
Shape OVAL Size 25mm
Flavor CHERRY (Black Cherry) Imprint Code P
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72628-104-01 25 PASTILLE in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/26/2019
Labeler — Boston Nutraceutical Production SL (468121064)
Registrant — Boston Nutraceutical Science SL (466061824)
Establishment
Name Address ID/FEI Operations
Boston Nutraceutical Production SL 468121064 manufacture (72628-104), label (72628-104), pack (72628-104)

Revised: 03/2019 Boston Nutraceutical Production SL

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