Indications and uses
temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep
temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep
do not take more than directed (see Overdose warning) measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter; tsp = teaspoon adults and children 12 years of age and older: 20 mL (4 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours children under 12 years of age: do not use unless directed by a doctor
Each 20 mL contains: sodium 12 mg tamper evident: do not use if printed seal under cap is torn or missing Store at 20-25°C (68-77°F) do not refrigerate dosing cup provided
Active ingredients (in each 20 mL (4 tsp) dose)
Acetaminophen USP 650 mg
Diphenhydramine HCl USP 25 mg
Phenylephrine HCl USP 10 mg
Pain reliever/fever reducer
Antihistamine/cough suppressment
Nasal decongestant
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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.
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
ask a health professional before use.
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.
anhydrous citric acid, edetate disodium, FD&C Blue, FD&C Red, flavors, glycerin, noncrystallizing sorbitol solution, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum.
1-855-274-4122
You may also report side effects to this phone number.
Distributed by:
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
NDC 46122-359-30
Compare to Mucinex®
FAST-MAX®
NIGHTTIME COLD & FLU
active ingredients*
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Night Time Cold & Flu
Each dose 20 mL (4 tsp) of oral solution contains:
650 mg - acetaminophen USP (pain reliever/fever reducer)
25 mg - diphenhydramine HCl USP (antihistamine/cough suppressant)
10 mg - phenylephrine HCl USP (nasal decongestant)
For Ages 12+ 6 FL OZ (180 mL)
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 46122-359-30 | ML - Milliliter | 46122-359 | edd3e3a8-e76b-4464-a969-b3cde7af37f6 | 1 | 2020-04-20 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 46122-359 | 46122-359-30 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 35926f04-cb68-46d3-a75f-293163ab92f2 | 53b5e704-b3eb-4b1b-9463-a80edf8dcb18 | 2020-11-26 | Warnings | 35926f04-cb68-46d3-a75f-293163ab92f2 53b5e704-b3eb-4b1b-9463-a80edf8dcb18 |
Adverse event summaries are temporarily unavailable. Other product information remains available.