COUNTERACT COUGH DROPS ORCHARD CHERRY- menthol lozenge

CounterAct by

Drug Labeling and Warnings

CounterAct by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
(in each drop)
Menthol 7 mg

PURPOSE

Purpose
Cough suppressant, oral anesthetic

INDICATIONS & USAGE

Uses temporarily relieves:

• cough associated with a cold or inhaled irritants
• occasional minor irritation, pain, sore mouth, and sore throat
  

WARNINGS

Warnings
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.  Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

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 accompanied by a fever, rash, or persistent headache. These can be signs of a serious condition.
• sore mouth does not improve in 7 days
• irritation, pain, or redness persists or worsens
  

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

• adults and children 5 years and over: dissolve 1 drop slowly in the mouth. May be repeated every hour as needed or as directed by a doctor.
• children under 5 years: ask a doctor
  

STORAGE AND HANDLING

Other information

• store at room temperature
• protect from moisture and heat
  

INACTIVE INGREDIENT

Inactive ingredients  ascorbic acid, cherry flavor (artificial), corn syrup, fruit and vegetable extracts, sodium ascorbate, sucrose, T40-C3 brand Melaleuca Oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COUNTERACT  COUGH DROPS ORCHARD CHERRY
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-297
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7 mg

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CORN SYRUP (UNII: 9G5L16BK6N)
SODIUM ASCORBATE (UNII: S033EH8359)
SUCROSE (UNII: C151H8M554)
TEA TREE OIL (UNII: VIF565UC2G)

Product Characteristics
Color	red (Purplish Red)	Score	no score
Shape	OVAL (Drops)	Size	22mm
Flavor	CHERRY (Orchard Cherry)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-297-30	30 in 1 BAG; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/20/2008

Labeler - Melaleuca, Inc. (139760102)