OTC - ACTIVE INGREDIENT SECTION
Acetaminophen 100 mg
Caffeine 2 mg
Chlorpheniramine Maleate 2 mg
Purpose
Pain reliever/fever reducer
Pain reliever aid
Antihistamine
Warnings
Liver warningThis product contains acetaminophen, Severe liver damage many occur if you take ■ more than 6 packets in 24 hours, which is the maximum daily amount for this product ■with other drugs containing acetaminophen ■3 or more alcoholic drinks daily while using this product.
Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Ask a doctor before using if you have
• Glaucoma • A breathing problem such as emphysema or chronic bronchitis • Difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are ■have liver disease ■are taking sedatives or tranquilizers ■ are taking the blood thinner drug, warfarin
When using this product ■ May cause excitability, especially in children ■ May cause drowsiness, if used with alcohol, sedatives, or tranquilizers ■ Use caution when driving a motor vehicle or operating machinery.
Stop use and consult a doctor ■ If pain or fever persists or worsen ■ If redness or swelling is present ■ If symptoms last for more than 7 days ■ Fever lasts more than 3 days ■ If new symptoms occur such as rash, nausea or vomiting.
If pregnant or breast-feeding ask a health professional before using.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms. Do not exceed recommended
Directions■ Adults and children 12 years of age and older: Take 2 capsules 3 times a day. Do not exceed 12 capsules in 24 hours.
■ Children under 12 years of age: Consult a doctor before using.
Other Information
■ Protect form light and excessive heat ■ Keep tightly closed ■ Keep in dry place
Other Ingredients
Chrysanthemum (flower), Evodia (unripe fruit), Roughhaired Holly (root), Spanish needles, Peppermint oil.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1303251 | acetaminophen 100 MG / caffeine 2 MG / chlorpheniramine maleate 2 MG Oral Capsule | PSN | 1 |
| 1303251 | acetaminophen 100 MG / caffeine 2 MG / chlorpheniramine maleate 2 MG Oral Capsule | SCD | 1 |
| 1303251 | APAP 100 MG / Caffeine 2 MG / Chlorpheniramine Maleate 2 MG Oral Capsule | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63922-601-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-bbb5-f6ea-e053-dbdaa90aa703 | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63922-601-01 | 999 GANMAOLINGCold | 1 in 1 BOX | CAPSULE | 1 | 1 | |
| 63922-601-12 | 999 GANMAOLINGCold | 12 in 1 BLISTER PACK | CAPSULE | 12 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| CAFFEINE | ACTIVE INGREDIENT | 3G6A5W338E | 1 | |
| CHLORPHENIRAMINE MALEATE | ACTIVE INGREDIENT | V1Q0O9OJ9Z | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | 1 | |
| CHLORPHENIRAMINE | ACTIVE MOIETY | 3U6IO1965U | 1 | |
| BIDENS BIPINNATA WHOLE | INACTIVE INGREDIENT | TRQ4JQ7DJQ | 1 | |
| DENDRANTHEMA INDICUM FLOWER | INACTIVE INGREDIENT | I6OER6U04L | 1 | |
| ILEX PUBESCENS ROOT | INACTIVE INGREDIENT | V5V22LFX73 | 1 | |
| PEPPERMINT OIL | INACTIVE INGREDIENT | AV092KU4JH | 1 | |
| TETRADIUM RUTICARPUM FRUIT | INACTIVE INGREDIENT | Q413WWJ3X9 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63922-601 | 63922-601-12, 63922-601-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| DENDRANTHEMA INDICUM FLOWER | I6OER6U04L | IACT |
| TETRADIUM RUTICARPUM FRUIT | Q413WWJ3X9 | IACT |
| ILEX PUBESCENS ROOT | V5V22LFX73 | IACT |
| BIDENS BIPINNATA WHOLE | TRQ4JQ7DJQ | IACT |
| PEPPERMINT OIL | AV092KU4JH | 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 |
|---|---|---|---|---|---|---|
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | LOZENGE / ORAL | 12 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SOLUTION / DENTAL | 0.04 %v/v | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SUSPENSION / ORAL | 100 mg/1ml | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | ELIXIR / ORAL | 0.04 mg/1ml | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | TABLET / ORAL | 28 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | TABLET / SUBLINGUAL | 0.15 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | CONCENTRATE / ORAL | 0.05 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SYRUP / ORAL | 120 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | GUM, CHEWING / BUCCAL | 526 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | POWDER, DENTIFRICE / DENTAL | NA | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | GUM, CHEWING / ORAL | 526 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | PASTE, DENTIFRICE / DENTAL | 49.3 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SOLUTION / ORAL | 53 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | FILM / BUCCAL | 12 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SPRAY, METERED / SUBLINGUAL | 1 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | POWDER / SUBLINGUAL | 1 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SHAMPOO / TOPICAL | 0.2 %w/w | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | CAPSULE / ORAL | 60 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 |
|---|---|---|---|---|---|---|
| db0a71dd-c5fa-4580-b085-9895586d953a | efebbec1-c478-462d-adb9-a01d71a7966f | 2012-07-03 | Warnings | db0a71dd-c5fa-4580-b085-9895586d953a efebbec1-c478-462d-adb9-a01d71a7966f |
Adverse event summaries are temporarily unavailable. Other product information remains available.