Nighttime Severe Cold and Cough
Acetaminophen, Diphenhydramine, Phenylephrine · Powder, For Solution · Oral
Active ingredient
Active ingredients (in each packet) Acetaminophen 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg
Purpose
Purposes Pain reliever / fever reducer Antihistamine / Cough Suppressant Nasal Decongestant
Uses
Uses ▪ temporarily relieves these symptoms due to a cold: ▪ minor aches and pains ▪ minor sore throat pain ▪ headache ▪ nasal and sinus congestion ▪ runny nose ▪ sneezing ▪ itchy nose or throat ▪ itchy, watery eyes due to hay fever ▪ cough due to minor throat and bronchial irritation ▪ temporarily reduces fever
Warnings
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 reactions, Symptoms may include: ▪ skin reddening ▪ blisters ▪ rash 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.
Do not use
Do not use ▪ in a child under 12 years of age ▪ if you are allergic to acetaminophen ▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist. ▪ with any other product containing diphenhydramine, even one used on the skin ▪ 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 a MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use
Ask a doctor before use if you have ▪ liver disease ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ glaucoma ▪ trouble urinating due to an enlarged prostate gland ▪ a breathing problem such as emphysema, asthma or chronic bronchitis ▪ cough that occurs with too much phlegm (mucus) ▪ cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are ▪ taking sedatives or tranquilizers ▪ taking the blood thinning drug warfarin
When using this product
When using this product ▪ do not exceed recommended dosage ▪ avoid alcoholic drinks ▪ marked drowsiness may occur ▪ 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 a doctor
Stop use and ask a doctor if ▪ nervousness, dizziness, or sleeplessness occurs ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ pain, cough or nasal congestion gets worse or lasts more than 7 days ▪ cough comes back or occurs with fever, rash or headache that lasts. There could be signs of a serious condition.
Pregnancy or breast-feeding
If pregnant or breast- feeding, ask a health care professional before use.
Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Directions ▪ do not use more than directed ▪ take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use ▪ dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes. ▪ if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.
Other information
Other information ▪ each packet contains: potassium 6 mg ▪ store at room temperature. Protect from excessive heat and moisture.
Inactive ingredients
Inactive ingredients citric acid, FD& C Yellow No. 6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,
Questions?
Questions or comments? 1- 866-467-2748
Label text from the FDA structured product label by RARITAN PHARMACEUTICALS INC (revised Sep 8, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 3 products
- Diphenhydramine Hydrochloride in 3 products
- Phenylephrine Hydrochloride in 3 products
Nighttime Severe Cold and Cough NDC products (3)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 41226-541 | Acetaminophen 650 mg/1; Diphenhydramine Hydrochloride 25 mg/1; Phenylephrine Hydrochloride 10 mg/1 Powder, For Solution | KROGER COMPANY | OTC MONOGRAPH DRUG |
| 49580-0502 | Acetaminophen 650 mg/30mL; Diphenhydramine Hydrochloride 25 mg/30mL; Phenylephrine Hydrochloride 10 mg/30mL Liquid | P & L Development, LLC | OTC MONOGRAPH DRUG |
| 68163-541 | Acetaminophen 650 mg/1; Diphenhydramine Hydrochloride 25 mg/1; Phenylephrine Hydrochloride 10 mg/1 Powder, For Solution | RARITAN PHARMACEUTICALS INC | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Nighttime Severe Cold and Cough used for?
Uses ▪ temporarily relieves these symptoms due to a cold: ▪ minor aches and pains ▪ minor sore throat pain ▪ headache ▪ nasal and sinus congestion ▪ runny nose ▪ sneezing ▪ itchy nose or throat ▪ itchy, watery eyes due to hay fever ▪ cough due to minor throat and bronchial irritation ▪ temporarily reduces fever
Who makes Nighttime Severe Cold and Cough?
Nighttime Severe Cold and Cough is listed by 3 labelers in the FDA NDC directory, including KROGER COMPANY, P & L Development, LLC, RARITAN PHARMACEUTICALS INC.