MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU
- Manufacturer
- CVS Pharmacy, Inc. | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2026-03-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:51:35
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each softgel)
Daytime Cold & Flu
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Active ingredients (in each softgel)
Nighttime Cold & Flu
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
OTC - PURPOSE SECTION
Purposes
Daytime Cold & Flu
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Purposes
Nighttime Cold & Flu
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves these common cold and flu symptoms:
- sinus congestion and pressure
- cough
- minor aches and pains
- headache
- nasal congestion
- sore throat
- runny nose and sneezing (
Nighttime only)
- itchy, watery eyes due to hay fever (
Nighttime only)
- itching of the nose or throat (
Nighttime only)
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ( Daytime only)
- controls cough to help you get to sleep
- temporarily reduces fever
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 softgels in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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.
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- glaucoma ( Nighttime only)
- breathing problems such as emphysema or chronic bronchitis ( Nighttime only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers ( Nighttime only)
OTC - WHEN USING SECTION
When using this product
- do not use more than directed
- excitability may occur, especially in children ( Nighttime only)
- marked drowsiness may occur ( Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness ( Nighttime only)
- avoid alcoholic drinks ( Nighttime only)
- be careful when driving a motor vehicle or operating machinery ( Nighttime only)
OTC - STOP USE SECTION
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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with fever, rash, or headache that lasts.
These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 12 softgels in any 24-hour period
- adults and children 12 years of age and over: take 2 softgels every 4 hours
- children under 12 years of age: do not use
OTHER INFORMATION
Other information
- store at 20-25°C (68-77°F)
- avoid excessive heat
INACTIVE INGREDIENT SECTION
Inactive ingredients (Daytime only)
FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water
Inactive ingredients (Nighttime only)
FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water
OTC - QUESTIONS SECTION
Questions or comments? C all 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
CVS 630T Daytime Nighttime Cold & Flu
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2634364 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } Pack | GPCK | 4 |
| 2634364 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack | PSN | 4 |
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 4 |
| 1656815 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 4 |
| 1297288 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 4 |
| 1656815 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 4 |
| 2634364 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack | SY | 4 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 4 |
| 1656815 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 4 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE 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 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69842-451-24 | 2025-02-13 | C162847 | 48780-1 | 2cef2736-87f5-d83d-e063-dadaa90ab31f | 630T CVS 69842-451 MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU |
| 69842-451-24 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-87f5-d83d-e063-dadaa90ab31f | 630T CVS 69842-451 MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-094-16 | MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU | 16 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 16 | 5 mg | 4 |
| 69842-382-08 | MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | 5 mg | 4 |
| 69842-451-24 | MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU | 1 in 1 BLISTER PACK | KIT | 1 | 4 | |
| 69842-451-24 | MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU | 1 in 1 CARTON | KIT | 1 | 4 |
Products#
Every source-derived product name is available through these pages.
- MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
- MAXIMUM STRENGTH DAYTIME COLD AND FLU
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- SORBITOL
- FD&C YELLOW NO. 6 ALUMINUM LAKE
- POVIDONE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- ACETAMINOPHEN
- SHELLAC
- TITANIUM DIOXIDE
- GUAIFENESIN
- GELATIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GLYCERIN
- MAXIMUM STRENGTH NIGHTTIME COLD AND FLU
- Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- FD&C BLUE NO. 1 ALUMINUM LAKE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-451 | 69842-451-24 |
| 69842-094 | 69842-094-16 |
| 69842-382 | 69842-382-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy, Inc. | c17b8f17-95f6-37e4-e053-2995a90a411a | 2026-03-26 | Warnings | 69842-094-16 69842-451-24 69842-382-08 69842-451 69842038208 69842009416 69842045124 4de96330-ff57-5acf-e063-6394a90a8375 c17b8f17-95f6-37e4-e053-2995a90a411a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
