MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA
- Manufacturer
- FAMILY DOLLAR | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LTD
- Effective date
- 2025-02-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:55:27
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each SOFTGEL)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine Succinate 6.25 mg
Phenylephrine hydrochloride 5 mg
OTC - PURPOSE SECTION
- Pain Reliever-Fever Reducer
- Cough Suppressant
- Antihistamine
- Nasal Decongestant
INDICATIONS & USAGE SECTION
Uses
· temporarily relieves these symptoms due to a cold or flu:
· minor aches and pains · headache · cough
· sore throat · nasal and sinus congestion
· temporarily reduces fever
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
· more than 4,000 mg of acetaminophen in 24 hours
· with other drugs containing acetaminophen
· 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic 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 - 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(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 the recommended dose
· adults and children 12 years and over: take 2 softgels 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
INACTIVE INGREDIENT SECTION
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 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 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 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 |
| 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 |
| 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 |
|---|---|---|---|---|---|
| 55319-934-08 | 2025-02-15 | C162847 | 48780-1 | 2cef2736-a07a-d83d-e063-dadaa90ab31f | 633T FAMILY DOLLAR NIGHT MAXIMUM STRENGTH COLD AND FLU 55319-934-08 |
| 55319-934-08 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a07a-d83d-e063-dadaa90ab31f | 633T FAMILY DOLLAR NIGHT MAXIMUM STRENGTH COLD AND FLU 55319-934-08 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-934-08 | MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55319-934 | MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250217_aa8f0465-1595-0b0f-e053-2a95a90a0081.zip |
Products#
Every source-derived product name is available through these pages.
- MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA
- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- WATER
- SHELLAC
- SORBITOL
- TITANIUM DIOXIDE
- FD&C BLUE NO. 1
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- GLYCERIN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- GELATIN
- ACETAMINOPHEN
- POVIDONE
- PROPYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55319-934 | 55319-934-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| SHELLAC | 46N107B71O | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| GELATIN | 2G86QN327L | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
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 DAY-NIGHT COLD AND FLU FORMULA | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL | FAMILY DOLLAR | aa8f6dd0-d19f-0c10-e053-2a95a90a1e8a | 2025-02-15 | Warnings | 55319-934-08 55319093408 |
| MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | FAMILY DOLLAR | aa8f0465-1595-0b0f-e053-2a95a90a0081 | 2025-02-15 | Warnings | 55319-934-08 55319-934 55319093408 2e2d4866-655f-2359-e063-6294a90a4b72 aa8f0465-1595-0b0f-e053-2a95a90a0081 |
