Uses ■ for the temporary relief of the following cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ cough ■ impulse to cough ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive ■ temporarily reduces fever
Directions adults and children 12 years and over ■ take 2 tablets with water every 6-8 hours as needed ■ do not take more than 8 tablets in 24 hours, or as directed by a doctor children under 12 years of age ask a doctor
Other information ■ store at room temperature 59-86˚ F (15-30˚ C)
Drug Facts
Active ingredients (in each tablet)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Guaifenesin 200 mg
Phenylephrine HCI 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Uses
■ for the temporary relief of the following cold/flu symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ nasal congestion
■ cough
■ impulse to cough
■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
■ temporarily reduces fever
Liver warning: This product contains acetaminophen. Severe liver damage
may occur if you take:
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening
■ blisters
■ rash
If a skin reaction occurs, stop use and seek medical help right away.
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.
A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Do not use
■ 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 are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
■ liver disease
■ heart disease
■ diabetes
■ thyroid disease
■ high blood pressure
■ trouble urinating due to an enlarged prostate gland
■ cough that occurs with too much phlegm (mucus)
■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
When using this product
■ do not exceed recommended dosage
Stop use and ask a doctor if
■ pain, nasal congestion or cough 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
■ cough comes back or is accompanied by a fever, rash or persistent headache
■ nervousness, dizziness, or sleeplessness occur.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
adults and children 12 years and over | ■ take 2 tablets with water every 6-8 hours as needed ■ do not take more than 8 tablets in 24 hours, or as directed by a doctor |
children under 12 years of age | ask a doctor |
Other information
■ store at room temperature 59-86˚ F (15-30˚ C)
Inactive ingredients
maltodextrin, microcrystalline cellulose, povidone, silicon dioxide*, sodium starch glycolate, starch, stearic acid
*may contain
Questions or comments?
call toll-free
1-877-507-6516 (M-F 8AM-4:30PM CST)
Cold
Acetaminophen, Dextromethorphan HBr,
Guaifenesin, Phenylephrine HCl
SEVERE
CONGESTION
Non-Drowsy Relief of
[barcode]
3 66715 97187 6
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1367204 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 1 |
| 1367204 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 1 |
| 1367204 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66715-9818-7 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-67d7-198a-e063-dbdaa90aec3e | Cold Severe Congestion |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66715-9818-7 | Cold Severe Congestion | 50 in 1 BOX, UNIT-DOSE | TABLET | 50 | 1 | |
| 66715-9818-7 | Cold Severe Congestion | 2 in 1 POUCH | TABLET | 2 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66715-9818 | COLD SEVERE CONGESTION (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE TABLET) TABLET [LIL' DRUG STORE PRODUCTS, INC.] | 1 | Legacy NDC, 2 package rows | 20220827_e5d4520d-3bae-9916-e053-2995a90ae273.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 66715-9818 | 66715-9818-7 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
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 |
|---|---|---|---|---|---|---|
| e5d4520d-3baf-9916-e053-2995a90ae273 | e5d4520d-3bae-9916-e053-2995a90ae273 | 2022-08-09 | Warnings | e5d4520d-3baf-9916-e053-2995a90ae273 e5d4520d-3bae-9916-e053-2995a90ae273 |
Adverse event summaries are temporarily unavailable. Other product information remains available.