OTC - ACTIVE INGREDIENT SECTION
Active ingredient
(in each drop)
Menthol 7 mg
Active ingredient
(in each drop)
Menthol 7 mg
Purpose
Cough suppressant, oral anesthetic
Uses temporarily relieves:
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.
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 a doctor if:
■ cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
■ sore mouth does not improve in 7 days
■ irritation, pain, or redness persists or worsens
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
15 calories per drop
store at room temperature
protect from moisture and heat
Inactive ingredients
sucrose, corn syrup, natural flavor, annatto extract, T40-C3 Melaleuca oil, sodium ascorbate, ascorbic acid
Indications and Usage section verbiage slightly changed FROM:
■ cough associated with a cold or inhaled ingredients ■ occasional minor irritation, pain, sore mouth, and sore throat
TO:
■ cough due to cold ■ occasional minor irritation or sore throat"
Dosage and Administration section changed FROM:
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
TO:
■ 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
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54473-297-30 | 2020-03-19 | C162847 | 48780-1 | 9d75b9d0-3d51-f424-e053-dadaa90a57ce | CounterAct Cough Drops Orchard Cherry Content of Label |
| 54473-297-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3d51-f424-e053-dadaa90a57ce | CounterAct Cough Drops Orchard Cherry Content of Label |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54473-297-31 | CounterActCough Drops Orchard Cherry | 30 in 1 BAG | LOZENGE | 30 | 8 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 2 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 2 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | 2 | |
| CORN SYRUP | INACTIVE INGREDIENT | 9G5L16BK6N | 2 | |
| SODIUM ASCORBATE | INACTIVE INGREDIENT | S033EH8359 | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 2 | |
| TEA TREE OIL | INACTIVE INGREDIENT | VIF565UC2G | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54473-297 | 54473-297-31 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CORN SYRUP | 9G5L16BK6N | IACT |
| SODIUM ASCORBATE | S033EH8359 | IACT |
| ASCORBIC ACID | PQ6CK8PD0R | IACT |
| SUCROSE | C151H8M554 | IACT |
| TEA TREE OIL | VIF565UC2G | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| CHERRY | BUC5I9595W | IACT |
| ANNATTO | 6PQP1V1B6O | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | SUSPENSION / ORAL | 2500 mg/5ml | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | SUSPENSION / ORAL | 2500 mg/5ml | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | SYRUP / ORAL | 600 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | SYRUP / ORAL | 200 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | CAPSULE / ORAL | 7 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| SODIUM ASCORBATE | SODIUM ASCORBATE | S033EH8359 | CAPSULE / ORAL | 6 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | SYRUP / ORAL | 600 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | CONCENTRATE / ORAL | 6 mg/1ml | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | POWDER, FOR SOLUTION / ORAL | 560 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | CONCENTRATE / ORAL | 6 mg/1ml | ||
| SUCROSE | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | SOLUTION / ORAL | 750 mg/5ml | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | CAPSULE, DELAYED RELEASE / ORAL | 12 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| SODIUM ASCORBATE | SODIUM ASCORBATE | S033EH8359 | SUSPENSION, EXTENDED RELEASE / ORAL | 33 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | CAPSULE, EXTENDED RELEASE / ORAL | 28.5 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | TABLET / ORAL | 80 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| SODIUM ASCORBATE | SODIUM ASCORBATE | S033EH8359 | TABLET / ORAL | 30 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | SOLUTION / ORAL | 750 mg/5ml | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | TABLET, FILM COATED / ORAL | 20 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | TABLET, ORALLY DISINTEGRATING / ORAL | 2.35 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | SYRUP / ORAL | 200 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | TABLET, FILM COATED / ORAL | 20 mg | ||
| CORN SYRUP | CORN SYRUP | 9G5L16BK6N | ELIXIR / ORAL | 400 mg/1ml | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | TABLET / ORAL | 80 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CounterAct Cough Drops Orchard Cherry | MENTHOL | Melaleuca, Inc. | 6049842c-d763-4a91-a225-976ed74e1693 | 2026-05-15 | Warnings | 54473-297-31 54473-297 54473029731 51df9c76-7f44-29f4-e063-6294a90ae30f 6049842c-d763-4a91-a225-976ed74e1693 |
Adverse event summaries are temporarily unavailable. Other product information remains available.