Indications and uses
temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough nasal and sinus congestion temporarily reduces fever
Multi-Symptom Daytime and Nighttime Cold and Flu Relief Plus
- Manufacturer
- Walgreens Company | Apotex Inc. | Accucaps Industries Limited | Accucaps Industries Limited Strathroy | Legacy Pharmaceutical Packaging
- Effective date
- 2015-05-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:31:53
Label at a glance#
ProductMulti-Symptom Daytime and Nighttime Cold and Flu Relief Plus
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure16 sections
Dosage and administration
do not take more than the recommended dose adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. children under 12 years: do not use
Contacts and useful links#
Label contents#
Full prescribing information#
SPL PRODUCT DATA ELEMENTS SECTION
SPL UNCLASSIFIED SECTION
Active ingredients for DAYTIME ONLY (in each LiquidCap)
Acetaminophen
Dextromethorphan hydrobromide
Phenylephrine hydrochloride
Active ingredients for NIGHTTIME (in each LiquidCap)
Acetaminophen
Dextromethorphan hydrobromide
Doxylamine succinate
Phenylephrine hydrochloride
Purpose (DAYTIME ONLY)
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Purpose (NIGHTTIME ONLY)
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses (DAYTIME ONLY)
temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- cough
- nasal and sinus congestion
- temporarily reduces fever
Uses (NIGHTTIME ONLY)
temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- nasal and sinus congestion
- cough
- sore throat
- runny nose
- temporarily reduces fever
Warnings (DAYTIME ONLY)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 10 capsules in 24 hours, which is the maximum daily amount for this product
- 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. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- 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.
- in children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough with excessive phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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
Stop use and ask 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 occurs with rash or headache that lasts
- nervousness, dizziness, or sleeplessness occurs
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Warnings (NIGHTTIME ONLY)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 10 capsules in 24 hours, which is the maximum daily amount for this product
- 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 to sedate children.
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.
- 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.
- in children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- cough with excessive phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask 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 occurs with rash or headache that lasts
- nervousness, dizziness, or sleeplessness occurs
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions (DAYTIME ONLY)
- do not take more than the recommended dose
- adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
- children under 12 years: do not use
Directions (NIGHTTIME)
- do not take more than the recommended dose
- adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
- children under 12 years: do not use
Other Information
- store at controlled room temperature 15°C to 30°C (59°F to 86°F)
Inactive ingredients (DAYTIME ONLY)
FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sortitian, sorbitol
Inactive ingredients (NIGHTTIME)
D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sortitian, sorbitol
Questions or comments?
1-800-706-5575
Principal Display Panel
Combo Pack
MULTI-SYMPTOM NON-DROWSY • DAYTIME
Cold & Flu Relief Plus
Acetaminophen
Aches/Fever/Sore Throat
Dextromethorphan HBr/Cough
Phenylephrine HCl/Nasal Congestion
12 LIQUID GELS
MULTI-SYMPTOM • NIGHTTIME
Cold & Flu Relief Plus
Aches/Fever/Sore Throat
Dextromethorphan HBr/Cough
Doxylamine Succinate/Sneezing/Runny Nose
8 LIQUID CAPS
Compare to Alka Seltzer PLUS® active ingredients‡‡
20 TOTAL LIQUID GELS
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-1031-02 | 2020-08-14 | C162847 | 48780-1 | 9d75b9d1-2091-f424-e053-dadaa90a57ce | MULTI-SYMPTOM DAYTIME AND NIGHTTIME COLD & FLU RELIEF PLUS |
| 0363-1031-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2091-f424-e053-dadaa90a57ce | MULTI-SYMPTOM DAYTIME AND NIGHTTIME COLD & FLU RELIEF PLUS |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-1031-02 | EA - Each | 0363-1031 | e752ae34-fcdc-4b2d-89bf-e16ac5b24fcb | 1 | 2018-04-19 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| DOXYLAMINE SUCCINATE | ACTIVE INGREDIENT | V9BI9B5YI2 | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| DOXYLAMINE | ACTIVE MOIETY | 95QB77JKPL | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Multi-Symptom Daytime and Nighttime Cold and Flu Relief Plus
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
- Multi-Symptom Day Time Cold and Flu Relief Plus
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- GLYCERIN
- MANNITOL
- POLYETHYLENE GLYCOLS
- POVIDONE
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- Multi-Symptom Night Time Cold and Flu Relief Plus
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- POVIDONES
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-1031 | 0363-1031-02 |
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 |
|---|---|---|---|---|---|---|
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRAVENOUS | 20 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, DELAYED RELEASE / ORAL | 19 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 17 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CONCENTRATE / INTRAVENOUS | 220 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | POWDER / RESPIRATORY (INHALATION) | 6 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 17 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | LOZENGE / ORAL | 20546 mg | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / NASAL | 50 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, ORALLY DISINTEGRATING / ORAL | 12 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, DELAYED RELEASE / ORAL | 1 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / INTRAVENOUS | 15400 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, DELAYED RELEASE / ORAL | 2 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, DELAYED RELEASE / ORAL | 0.02 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| GELATIN | GELATIN | 2G86QN327L | GUM, CHEWING / BUCCAL | 102 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER / ORAL | 20 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | POWDER, FOR SUSPENSION / ORAL | 35 mg/5ml | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | FILM / SUBLINGUAL | 0.03 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / OPHTHALMIC | 6 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 350 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 14 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, DELAYED RELEASE / ORAL | 1.9 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | PASTE / DENTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED / ORAL | 0.03 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / ORAL | 60.02 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SUSPENSION, EXTENDED RELEASE / ORAL | 1 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | AEROSOL, FOAM / TOPICAL | 4.95 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SUSPENSION / ORAL | 76 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / SUBLINGUAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 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 |
|---|---|---|---|---|---|---|
| 0027cc72-127f-453c-8221-375bbdb91d42 | 7b23d8dc-3ca0-90a9-964e-9ca2dfdf64b0 | 2020-08-14 | Warnings | 7b23d8dc-3ca0-90a9-964e-9ca2dfdf64b0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.