Indications and uses
temporarily relieves theses common cold symptoms: minor aches and pains headache nasal congestion cough sore throat sinus congestion and pressure helps clear nasal passages
Head Congestion Cold Relief
- Manufacturer
- WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | L.N.K. International, Inc. | L.N.K. International, Inc
- Effective date
- 2010-08-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:25:48
Label at a glance#
ProductHead Congestion Cold Relief
Active ingredientAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Label structure16 sections
Dosage and administration
do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 12 caplets in 24 hours children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
Storage and handling
store at controlled room temperature 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients
(in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves theses common cold symptoms:
- minor aches and pains
- headache
- nasal congestion
- cough
- sore throat
- sinus congestion and pressure
- helps clear nasal passages
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day 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 vommiting, consult a doctor promptly.
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
- diabetes
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- heart disease
- liver disease
- cough that occurs with too much phlegm (mucus)
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
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts.
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.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over
- take 2 caplets every 4 hours
- swallow whole - do not crush, chew, or dissolve
- do not take more than 12 caplets in 24 hours
- children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
Other information
- store at controlled room temperature 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, croscarmellose sodium, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, sucralose, talc, titanium dioxide
Questions or comments?
Call 1-800-426-9391
PRODUCT PACKAGING
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
CVS®
pharmacy
Compare to the active
ingredients of Tylenol® Cold
Head Congestion Daytime*
See New Warnings
Information
HEAD CONGESTION
COLD RELIEF
PAIN RELIEVER, NASAL DECONGESTANT,
COUGH SUPPRESSANT
DAYTIME
NON-DROWSY
CONTAINS 3 MEDICINES
Headache Pain -
- Acetaminophen
Sore Throat -
Nasal Congestion - Phenylephrine HCl
Coughing - Dextromethorphan HBr
12 COOL ICE® CAPLETS
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPNENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 REV1009A47002
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2010 CVS/pharmacy
www.cvs.com 1-800-shop-CVS
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1094538 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 1 |
| 1094538 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 1 |
| 1094538 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59779-470-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-af66-f424-e053-dadaa90a57ce | ebe9d74d-d382-1cdc-a5ea-94070cb5e6ac |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59779-470-01 | Head Congestion Cold Relief | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 | |
| 59779-470-01 | Head Congestion Cold Relief | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59779-470 | HEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] | 1 | Legacy NDC, 2 package rows | 20100914_ebe9d74d-d382-1cdc-a5ea-94070cb5e6ac.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| Croscarmellose Sodium | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| Polyethylene Glycol | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| Polyvinyl Alcohol | INACTIVE INGREDIENT | 532B59J990 | 1 | |
| Povidone | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Starch, Corn | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| Sucralose | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Head Congestion Cold Relief
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
- Acetaminophen
- Dextromethorphan Hydrobromide
- Dextromethorphan
- Phenylephrine Hydrochloride
- Phenylephrine
- Starch, Corn
- Croscarmellose Sodium
- Magnesium Stearate
- Cellulose, Microcrystalline
- Polyethylene Glycol
- Polyvinyl Alcohol
- Povidone
- Silicon Dioxide
- Stearic Acid
- Sucralose
- Talc
- Titanium Dioxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59779-470 | 59779-470-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
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 |
|---|---|---|---|---|---|---|
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | TROCHE / ORAL | 60 mg | ||
| Povidone | POVIDONE | FZ989GH94E | TABLET, EXTENDED RELEASE / ORAL | 101 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EFFERVESCENT / ORAL | 1080 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 127 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| Talc | TALC | 7SEV7J4R1U | SUSPENSION, EXTENDED RELEASE / ORAL | 46 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING / ORAL | 80 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| Talc | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| Povidone | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| Povidone | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | TABLET / SUBLINGUAL | 12 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TROCHE / ORAL | 50 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| Talc | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | GUM, CHEWING / BUCCAL | 70 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| Polyvinyl Alcohol | POLYVINYL ALCOHOL | 532B59J990 | TABLET, COATED / ORAL | 0.7 mg | ||
| Talc | TALC | 7SEV7J4R1U | GRANULE / ORAL | 322 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION, EXTENDED RELEASE / ORAL | 16 mg | ||
| Povidone | POVIDONE | FZ989GH94E | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 350 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | SOLUTION / ORAL | 800 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| Talc | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE / ORAL | 150 mg | ||
| Povidone | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| Talc | TALC | 7SEV7J4R1U | DROPS / ORAL | NA | ||
| Polyvinyl Alcohol | POLYVINYL ALCOHOL | 532B59J990 | CREAM / VAGINAL | 0.5 %w/w | ||
| Povidone | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| bddddfc8-2fdf-7e68-7422-1c1656705a87 | ebe9d74d-d382-1cdc-a5ea-94070cb5e6ac | 2010-08-30 | Warnings | bddddfc8-2fdf-7e68-7422-1c1656705a87 ebe9d74d-d382-1cdc-a5ea-94070cb5e6ac |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.