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Nighttime Severe Cold and Cough drug information

ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
RARITAN PHARMACEUTICALS INC · ORAL

Product NDC: 68163-541

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
Labeler / manufacturerRARITAN PHARMACEUTICALS INC
RouteORAL
Drug classDrug class not supplied in source label
Product NDC68163-541
Label effective date2026-09-08

Official product label reference

Nighttime Severe Cold and Cough — RARITAN PHARMACEUTICALS INC

This page contains 16 source sections for ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE, oral route. Label set 9819155b-2713-42be-867e-16605e7643d0, version 8.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

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

Purpose

Purposes Pain reliever / fever reducer Antihistamine / Cough Suppressant Nasal Decongestant
Dosage and administration — label text
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. Table text from source: | Age | Dose | adults and children 12 years of age and over | one packet | children under 12 years of age | do not use
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.
Active ingredient
Active ingredients (in each packet) Acetaminophen 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg
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
While using this medicine
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
When to stop use and seek help
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.
Child safety
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.
Storage and handling
Other information ▪ each packet contains: potassium 6 mg ▪ store at room temperature. Protect from excessive heat and moisture.
Inactive ingredient
Inactive ingredients citric acid, FD& C Yellow No. 6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,
Questions
Questions or comments? 1- 866-467-2748
Unclassified section
Principal Display Panels *Compare to the active ingredients in Theraflu ® Nighttime Severe Cold & Cough* NDC# 68163-541-06 Nighttime Severe Cold & Cough ACETAMINOPHEN PAIN RELIEVER/FEVER REDUER DIPHENHYDRAMINE HCl ANTIHISTAMINE/ COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT • Aspartame free • Sodium Free Relieves: Body Ache & Fever • Cough • Fever • Headache • Nasal Congestion • Runny Nose • Sneezing • Sore Throat Pain 6 PACKETS Honey Lemon Flavor Infused with Chamomile & White Tea Flavors TAMPER EVIDENT: DO NOT USE IF INNER SEALED PACKET IS TORN Manufactured by: Raritan Pharmaceuticals 8 Joanna Court East Brunswick, NJ 08816 *This product is not manufactured or distributed by GSK consumer Healthcare, owner of the registered trademark THERAFLU ® Nighttime Severe Cold & Cough. Table text from source: | TAMPER EVIDENT: DO NOT USE IF INNER SEALED PACKET IS TORN

Official sources and product identifiers

Substances listed: ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

RxNorm identifiers: 1659960

Package NDC codes

68163-541-06

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.