Indications and uses
temporarily relieves these common cold symptoms: minor aches and pains headache cough sneezing and runny nose nasal congestion sinus congestion and pressure sore throat helps clear nasal passages relieves cough to help you sleep
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, Chlorpheniramine Maleate, 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
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever
Antihistamine
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves these common cold symptoms:
- minor aches and pains
- headache
- cough
- sneezing and runny nose
- nasal congestion
- sinus congestion and pressure
- sore throat
- helps clear nasal passages
- relieves cough to help you sleep
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 vomiting, 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, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease
- diabetes
- heart disease
- high blood pressure
- glaucoma
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
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, FD&C blue #1, FD&C blue #2, flavor, magnesium stearate, microcrystalline cellulose,polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Questions or comments?
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 Nighttime*
See New Warnings
Information
HEAD CONGESTION
COLD RELIEF
PAIN RELIEVER, NASAL DECONGESTANT,
COUGH SUPPRESSANT, ANTIHISTAMINE
NIGHTTIME
TO LET YOU SLEEP
CONTAINS 4 MEDICINES
Headache Pain -
- Acetaminophen
Sore Throat -
Nasal Congestion - Phenylephrine HCl
Coughing - Dextromethorphan HBr
Runny Nose - Chlorpheniramine Maleate
12 COOL ICE® CAPLETS
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 REV1009A47302
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2010 CVS/pharmacy
1-800-shop-CVS
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 1 |
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 1 |
| 1086991 | APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59779-473-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7c8d-f424-e053-dadaa90a57ce | 334ff224-40a6-180f-6af8-e13c105491ca |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59779-473-01 | Head Congestion Cold Relief | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 1 | |
| 59779-473-01 | Head Congestion Cold Relief | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59779-473 | HEAD CONGESTION COLD RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] | 1 | Legacy NDC, 2 package rows | 20100914_334ff224-40a6-180f-6af8-e13c105491ca.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Chlorpheniramine Maleate | ACTIVE INGREDIENT | V1Q0O9OJ9Z | 1 | |
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Chlorpheniramine | ACTIVE MOIETY | 3U6IO1965U | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| Fd&c Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| Fd&c Blue No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 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, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
- Acetaminophen
- Chlorpheniramine Maleate
- Chlorpheniramine
- Dextromethorphan Hydrobromide
- Dextromethorphan
- Phenylephrine Hydrochloride
- Phenylephrine
- Starch, Corn
- Fd&c Blue No. 1
- Fd&c Blue No. 2
- Magnesium Stearate
- Cellulose, Microcrystalline
- Polyethylene Glycol
- Polyvinyl Alcohol
- Povidone
- Silicon Dioxide
- Stearic Acid
- Sucralose
- Talc
- Titanium Dioxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59779-473 | 59779-473-01 |
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 |
|---|---|---|---|---|---|---|
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 144 mg | ||
| Fd&c Blue No. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET / BUCCAL | 0.01 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| Polyvinyl Alcohol | POLYVINYL ALCOHOL | 532B59J990 | IMPLANT / INTRAVITREAL | 0.12 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| Polyvinyl Alcohol | POLYVINYL ALCOHOL | 532B59J990 | SYSTEM / TOPICAL | 420 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| Fd&c Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| Povidone | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| Povidone | POVIDONE | FZ989GH94E | SUSPENSION/ DROPS / OPHTHALMIC | 0.6 %w/v | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| Talc | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg | ||
| Talc | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| Fd&c Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| Fd&c Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| Fd&c Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| Fd&c Blue No. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | CAPSULE, DELAYED RELEASE / ORAL | 0.22 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| Fd&c Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| Povidone | POVIDONE | FZ989GH94E | INJECTION / INTRAMUSCULAR | 0.2 %w/v | ||
| Talc | TALC | 7SEV7J4R1U | SUSPENSION, EXTENDED RELEASE / ORAL | 46 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| Povidone | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| Talc | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| Talc | TALC | 7SEV7J4R1U | SUSPENSION / ORAL | 234 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | FILM, SOLUBLE / ORAL | 33 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| Talc | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| Fd&c Blue No. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET / ORAL | 25 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 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 |
|---|---|---|---|---|---|---|
| 6012a1ca-ed31-f73c-c431-5bef413041e5 | 334ff224-40a6-180f-6af8-e13c105491ca | 2010-08-30 | Warnings | 6012a1ca-ed31-f73c-c431-5bef413041e5 334ff224-40a6-180f-6af8-e13c105491ca |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.