Nighttime Severe Cough and Cold

Manufacturer
CARDINAL HEALTH
Effective date
2021-02-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:53:55

Label at a glance#

ProductNighttime Severe Cough and Cold
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure17 sections

Indications and 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

Dosage and administration

▪ do not use more than directed ▪ take every 4 hours; not to exceed 5 packets in 24 hours or as directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet ▪ dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes. ▪ i...

Storage and handling

▪ each packet contains: potassium 6 mg ▪ store at controlled room temperature 20 o -25 o C (68 o -77 o F). Protect from excessive heat and moisture.

Label contents#

Full prescribing information#

Active ingredients (in each packet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Diphenhydramine hydrochloride 25 mg

Phenylephrine hydrochloride 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever / fever reducer

Antihistamine / Cough Suppressant

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

  • 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 SECTION

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

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

OTC - DO NOT USE SECTION

  • in a child under 4 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 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 if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a sodium-restricted diet
  • 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 before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • sedatives or tranquilizers
  • the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • 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 if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • symptoms do not get better or worsen
  • 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.

If pregnant or breast- feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • take every 4 hours; not to exceed 5 packets in 24 hours or as directed by a doctor

Age

Dose

children under 4 years of age

do not use

children 4 to under 12 years of age

do not use unless directed by a doctor

adults and children 12 years of age and over

one packet

  • 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

STORAGE AND HANDLING SECTION

  • each packet contains: potassium 6 mg
  • store at controlled room temperature 20o -25oC (68o-77oF). Protect from excessive heat and moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose, yellow#6

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Additional Information Listed On Other Panels

SPL UNCLASSIFIED SECTION

LEADER

NDC 70000-0128-1

Nighttime Severe Cold &Cough

Acetaminophen

Diphenhydramine HCl

Phenylephrine HCl

Pain reliever/ Fever reducer

Antihistamine/ Cough suppressant

Nasal Decongestant

Honey Lemon

Infused with Chamomile & White Tea Flavors

Naturally and Artificially Flavored

COMPARE TO THERAFLU® NIGHTTIME SEVERE COLD & COUGH* active ingredients *

100% Money Back Guarantee

Relieves:

  • Nasal Congestion, Cough,
  • Runny Nose, Sneezing,
  • Body Ache, Sore Throat Pain, Headache & Fever

6 PACKETS

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE, KEEP CARTON FOR REFERENCE, DO NOT DISCARD,

NIGHTTIME Severe Cough & Cold

Cardinal Health™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to care™ since 1979

TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.

©2017 CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® Nighttime Severe Cold & Cough.

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nighttime Severe Cold & Cough Honey lemon 6 packets
Nighttime Severe Cold & Cough Honey lemon 6 packets

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0128NIGHTTIME SEVERE COUGH AND COLD (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [CARDINAL HEALTH]3Legacy NDC20210205_6c133d12-773e-466e-aaea-d165a7d1df81.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0128-1EA - Each70000-012878462958-0592-48dc-b293-ef5275e21d0612019-06-19

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-012870000-0128-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9d200774-ba9a-4dd1-aa5f-45e2907f7faa6c133d12-773e-466e-aaea-d165a7d1df812026-02-16WarningsExact identifier
spl set id: 6c133d12-773e-466e-aaea-d165a7d1df81

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.