■temporarily relieves these symptoms of hay fever and other upper respiratory allergies: ■runny nose and sneezing ■itchy, watery eyes ■temporarily relieves these additional symptoms of hay fever or other respiratory allergies: ■headache ■minor aches and pains
■ do not take more than directed (see Liver warning) adults and children 12 years of age and over ■ take 2 caplets every 4 hours. ■swallow whole-do not crush, chew dissolve ■ do not take more than 12 capsules in 24 hours. ■ children under 12 years ask a doctor
Acetaminophen 250 mg
Chlorpheniramine Maleate 2 mg
Pain reliever
Antihistamine
■temporarily relieves these symptoms of hay fever and other upper respiratory allergies:
■runny nose and sneezing ■itchy, watery eyes
■temporarily relieves these additional symptoms of hay fever or other respiratory allergies:
■headache ■minor aches and pains
Liver warningThis product contains acetaminophen. The maximum daily dose of this product is 12 capsules in 24 hours. Severe liver damage many occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■with other drugs containing acetaminophen ■3 or more alcoholic drinks daily while using this product.
■with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
■if you have ever had an allergic reactionto this product or any of its ingredients
■to make a child sleepy
■ liver disease ■ trouble urinating due to an enlarged prostate gland
■ a breathing problem such as emphysema or chronic bronchitis ■ Glaucoma
■ taking the blood thinner drug, warfarin
■ taking sedatives or tranquilizers
■ do not exceed recommended dosage
■ drowsiness may occur ■alcohol, sedatives and tranquilizers may increase drowsiness
■ avoid alcoholic drinks ■be careful when driving a motor vehicle or operating machinery
■ excitability may occur, especially in children
■ nervousness, dizziness, or sleepleessness occur ■ pain gets worse or lasts more than 7 days
■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur
This could be signs of a serious condition
ask a health professional before
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.
■ do not take more than directed (see Liver warning)
adults and children 12 years of age and over
■ take 2 caplets every 4 hours. ■swallow whole-do not crush, chew dissolve
■ do not take more than 12 capsules in 24 hours. ■ children under 12 years ask a doctor
Caffeine, Carmine, Corn Starch, FDC Yellow 5, FDC Blue 1,hydroxy methylcellulose, Sugar
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63922-605-01 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4ee1-60a7-e053-dbdaa90a05bd | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63922-605-01 | KGSALLERGY SOOTHING | 1 in 1 BOX | CAPSULE, DELAYED RELEASE PELLETS | 1 | 1 | |
| 63922-605-12 | KGSALLERGY SOOTHING | 12 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE PELLETS | 12 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| CHLORPHENIRAMINE MALEATE | ACTIVE INGREDIENT | V1Q0O9OJ9Z | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| CHLORPHENIRAMINE | ACTIVE MOIETY | 3U6IO1965U | 1 | |
| CAFFEINE | INACTIVE INGREDIENT | 3G6A5W338E | 1 | |
| COCHINEAL | INACTIVE INGREDIENT | TZ8Z31B35M | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| HYDROXYMETHYL CELLULOSE | INACTIVE INGREDIENT | 273FM27VK1 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63922-605 | 63922-605-12, 63922-605-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| CAFFEINE | 3G6A5W338E | IACT |
| COCHINEAL | TZ8Z31B35M | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| HYDROXYMETHYL CELLULOSE | 273FM27VK1 | IACT |
| SUCROSE | C151H8M554 | 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 |
|---|---|---|---|---|---|---|
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| CAFFEINE | CAFFEINE | 3G6A5W338E | GRANULE / ORAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, FILM COATED / ORAL | 1.68 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / DENTAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CAPSULE, EXTENDED RELEASE / ORAL | 0.26 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| HYDROXYMETHYL CELLULOSE | HYDROXYMETHYL CELLULOSE | 273FM27VK1 | TABLET / ORAL | 8 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SUPPOSITORY / VAGINAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | LIQUID / ORAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, COATED / ORAL | 7.93 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION/ DROPS / ORAL | 90 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, EXTENDED RELEASE / ORAL | 194 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CREAM / TOPICAL | 0.01 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| HYDROXYMETHYL CELLULOSE | HYDROXYMETHYL CELLULOSE | 273FM27VK1 | CAPSULE, EXTENDED RELEASE / ORAL | 1.6 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | POWDER / TOPICAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | OINTMENT / TOPICAL | 0.01 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET / BUCCAL | 0.11 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 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 |
|---|---|---|---|---|---|---|
| dc8d6626-3092-43cb-94c8-a2a02d4b321b | 0a205049-811f-4f66-ac29-cb2a7b4efbf0 | 2014-02-26 | Warnings | dc8d6626-3092-43cb-94c8-a2a02d4b321b 0a205049-811f-4f66-ac29-cb2a7b4efbf0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.