Storage and handling
Other information each 30 mL dose cup contains: potassium 4 mg sodium 33 mg store at room temperature
Family Care Cold and Flu Nighttime
- Manufacturer
- United Exchange Corp.
- Effective date
- 2015-07-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:43:10
Label at a glance#
ProductFamily Care Cold and Flu Nighttime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure14 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 30 mL dose cup) Purpose
Acetaminophen 650 mg....................................................Pain reliever/fever reducer
Dextromethorphan HBr 30 mg.....................................................Cough suppressant
Doxylamine succinate 12.5 mg............................................................Antihistamine
OTC - PURPOSE SECTION
Uses
temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
- running nose and sneezing
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning: if sore throat is severe, lasts for more than 2 days, occurs with or is 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 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
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
OTC - STOP USE SECTION
Stop use and ask a doctor if
- pain 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 occurs
- 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 our 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 & for children even if you do not notice any signs or symptoms.
INDICATIONS & USAGE SECTION
Directions
- take only as directed
- use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over: 30 mL (2 TBSP) every 6 hrs
children 4 to under 12 yrs: ask a doctor
children under 4 yrs: do not use
STORAGE AND HANDLING SECTION
Other information
- each 30 mL dose cup contains: potassium 4 mg
- sodium 33 mg
- store at room temperature
INACTIVE INGREDIENT SECTION
Inactive ingredietns
acesulfame potassium, alcohol, citric acid hydrate, FD&C Green No. 3, FD&C No. 5, glycerin, high fructose corn syrup, L-menthol, methylparaben, mint essence, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate hydrate, sodium chloride, sodium saccharin
DOSAGE & ADMINISTRATION SECTION
Distributed by:
United Exchange Corp.
Cerritos, CA 90703 U.S.A.
Made in Korea
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 1 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 1 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 1 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 1 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 1 |
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 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65923-629-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9edd-f424-e053-dadaa90a57ce | 85e15203-6d84-4361-877a-7342f070b938 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65923-629-04 | Family Care Cold and Flu Nighttime | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65923-629 | FAMILY CARE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [UNITED EXCHANGE CORP.] | 1 | Legacy NDC, 1 package rows | 20150730_85e15203-6d84-4361-877a-7342f070b938.zip |
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 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| DOXYLAMINE | ACTIVE MOIETY | 95QB77JKPL | 1 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | 1 | |
| HYDROXYCITRIC ACID | INACTIVE INGREDIENT | 8W94T9026R | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Family Care Cold and Flu Nighttime
- Acetaminophen, Dextromethorphan hydrobromide, and Doxylamine succinate
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- ACESULFAME POTASSIUM
- ALCOHOL
- HYDROXYCITRIC ACID
- FD&C GREEN NO. 3
- FD&C YELLOW NO. 5
- GLYCERIN
- HIGH FRUCTOSE CORN SYRUP
- MENTHOL
- METHYLPARABEN
- POLYETHYLENE GLYCOLS
- PROPYLPARABEN
- WATER
- SODIUM CHLORIDE
- SACCHARIN SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65923-629 | 65923-629-04 |
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 |
|---|---|---|---|---|---|---|
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACAUDAL | 210 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.8 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVENOUS | 2916 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | GEL / DENTAL | 0.3 %w/w | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, FILM COATED / ORAL | 1.75 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CREAM / TOPICAL | 0.1 %w/w | ||
| HIGH FRUCTOSE CORN SYRUP | HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | SUSPENSION / ORAL | 20000 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAPERITONEAL | 0.54 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / RECTAL | 271 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SUSPENSION / ORAL | 8 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 305 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | LIQUID / ORAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / RECTAL | 0.6 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR | 69 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRALESIONAL | 0.02 %w/v | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SYRUP / ORAL | 0.1 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | CAPSULE / ORAL | 40 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRABURSAL | 9 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / VAGINAL | 8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / INTRAMUSCULAR | 0.02 %w/v | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOAP / TOPICAL | 0.75 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| HIGH FRUCTOSE CORN SYRUP | HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | SUSPENSION, EXTENDED RELEASE / ORAL | 3000 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GEL / TOPICAL | 0.18 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 336 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | TABLET, DELAYED RELEASE / ORAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / EPIDURAL | 648 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SUSPENSION / ENDOTRACHEAL | 46.76 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | ELIXIR / ORAL | 15 mg/5ml | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | SHAMPOO / TOPICAL | 0.09 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RESPIRATORY (INHALATION) | 0.01 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / NASAL | 330 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION / ORAL | 3 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRA-ARTICULAR | 0.24 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / SUBCUTANEOUS | 0.8 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RECTAL | 0.02 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVASCULAR | 0.86 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / PARENTERAL | 2 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | CAPSULE, COATED PELLETS / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / EPIDURAL | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INFILTRATION | 648 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 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 |
|---|---|---|---|---|---|---|
| d9ec2557-0197-4f78-bca2-7d299bc04a16 | 85e15203-6d84-4361-877a-7342f070b938 | 2015-07-22 | Warnings | d9ec2557-0197-4f78-bca2-7d299bc04a16 85e15203-6d84-4361-877a-7342f070b938 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.