MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME
- Manufacturer
- RITE AID | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2022-12-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:52:38
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
daytime cold &flu
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
nighttime cold &flu
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
OTC - PURPOSE SECTION
daytime cold & flu
Purpose
Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant
nighttime cold & flu
Purpose
Pain reliever/Fever reducer
Cough suppressant
Antihistamine
INDICATIONS & USAGE SECTION
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion (Daytime only)
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- runny nose & sneezing (Nithttime only)
WARNINGS SECTION
Warnings
liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- wtth 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.
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
- glaucoma (nighttime only)
- heart disease (Daytime only)
- high blood pressure (Daytime only)
- thyroid disease (Daytime only)
- diabetes (Daytime only)
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
- a breathing problem or chronic cough that lasts or as occurs wtth smoking, asthma, chronic bronchitis or emphysema (nighttime only)
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
- taking the blood thining drug warfarin
OTC - WHEN USING SECTION
When using this product, do not use more than directed.(daytime only)
- excitability may occur, especially in children (nighttime only)
- marked drowsiness may occur (nighttime only)
- avoid alcoholic drinks (nighttime only)
- be carefull when driving a motor vehicle or operating machinery. (nighttime only)
- alcohol, sedatives, & tranquilizers may increase drowsiness. (nighttime only)
OTC - STOP USE SECTION
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless (daytime only)
- pain, nasal congestion or cough get worse or last more than 7 days (daytime only)
- pain or cough gets worse or lasts more than 7 days (nighttime only)
- 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.
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. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- take only as directed
- do not exceed 4 doses per 24 hours
adults & children 12 yrs & over: 2 softgels with water every 4 hrs (daytime only)
adults & children 12 yrs & over: 2 softgels with water every 6 hrs (nighttime only)
children 4 to under 12 yrs:ask a doctor
children under 4 yrs:do not use
OTHER INFORMATION
Other information
- store at room temperature
INACTIVE INGREDIENT SECTION
daytime cold & flu
Inactive ingredients FD&C red#40, FD&C yellow#6, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
nighttime cold & flu
Inactive ingredients FD&C blue#1, D&C yellow#10, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
OTC - QUESTIONS SECTION
Questions?call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2634564 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | 2 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | 2 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 2 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 2 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 2 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 2 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | 2 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 2 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 2 |
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 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-1988-0 | MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME | 1 in 1 BLISTER PACK | KIT | 1 | 2 | |
| 11822-1988-0 | MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME | 2 in 1 CARTON | KIT | 2 | 2 | |
| 11822-1988-9 | MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME | 1 in 1 BLISTER PACK | KIT | 1 | 2 | |
| 11822-1988-9 | MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME | 4 in 1 CARTON | KIT | 4 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-1988 | MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME (ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL AND ACETOMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE) KIT [RITE AID] | 2 | Legacy NDC, 4 package rows | 20221227_c95c4389-6684-05f3-e053-2a95a90a2267.zip |
Products#
Every source-derived product name is available through these pages.
- MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME
- Acetaminophen Dextromethorphan HBr Phenylephrine HCl and Acetominophen Dextromethorphan HBr Doxylamine Succinate
- MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME
- acetaminophen 325 mg dextromethorphan hbr 10 mg phenylephrine hci 5 mg
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- SORBITAN
- SHELLAC
- PROPYLENE GLYCOL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- WATER
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- GELATIN
- GLYCERIN
- MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME
- acetaminophen 325 mg dextromethorphan hbr 15 mg doxylamine succinate 6.25 mg
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- FD&C BLUE NO. 1
- D&C YELLOW NO. 10
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11822-1988 | 11822-1988-0, 11822-1988-9 |
| 11822-1989 | |
| 11822-1987 |
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 |
|---|---|---|---|---|---|---|
| MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME | ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 10 MG PHENYLEPHRINE HCI 5 MG | RITE AID | c92dbbbb-d149-1e7e-e053-2a95a90a6f1a | 2024-04-17 | Warnings | 11822-1989 |
| MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME | ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 15 MG DOXYLAMINE SUCCINATE 6.25 MG | RITE AID | c9323799-3505-d6c1-e053-2995a90a6f43 | 2024-04-17 | Warnings | 11822-1987 |
| f0b71e60-6bf0-5e2e-e053-2a95a90a3abd | c95c4389-6684-05f3-e053-2a95a90a2267 | 2022-12-26 | Warnings | f0b71e60-6bf0-5e2e-e053-2a95a90a3abd c95c4389-6684-05f3-e053-2a95a90a2267 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

