Kroger Nighttime Severe Cold And Cough Honey Lemon 6 Packets

Kroger Nighttime Severe Cold And Cough Honey Lemon 6 Packets
SPL v3
SPL
SPL Set ID 7def6781-0881-46bf-ad7a-7a3f23a8d9f7
Route
ORAL
Published
Effective Date 2024-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Diphenhydramine (25 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Yellow No. 6 Maltodextrin Potassium Chloride Silicon Dioxide Sucralose Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-15
Description

Acetaminophen, 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg

Purpose

Pain reliever / fever reducer Antihistamine / Cough Suppressant Nasal Decongestant

Medication Information

Purpose

Pain reliever / fever reducer Antihistamine / Cough Suppressant Nasal Decongestant

Description

Acetaminophen, 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg

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
Purposes

Pain reliever / fever reducer

Antihistamine / Cough Suppressant

Nasal Decongestant

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

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.

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

children under 12 years of age

do not use

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.
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.
Other Information
  • each packet contains: potassium 6 mg
  • aspartame free, sodium free
  • store at room temperature. Protect from excessive heat and moisture.
Principal Display
Inactive Ingredients

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

Questions Or Comments?

1-866-467-2748

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 If
  • 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.
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.

If Pregnant Or Breast Feeding,

ask a health care professional before use.

Active Ingredients (in Each Packet)

Acetaminophen, 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

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
Additional Information Listed On Other Panels

Compare to the active ingredient in Theraflu Nighttime Severe Cold &Cough*

NDC 41226-541-06

NIGHTTIME

SEVERE COLD

& COUGH

Acetaminophen/Pain Reliever/ Fever Reducer

Diphenhydramine HCl /

Antihistamine/ Cough Suppressant

Phenylephrine HCl / Nasal Decongestant

Relieves

  • Cough
  • Nasal Congestion
  • Sore Throat Pain
  • Headache
  • Body ache
  • Fever
  • Runny nose
  • Sneezing

Honey Lemon

Infused with Chamomile & White Tea Flavors

6 Packets

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

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

Distributed by:

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Nighttime Severe Cold & Cough.

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

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
Purposes

Pain reliever / fever reducer

Antihistamine / Cough Suppressant

Nasal Decongestant

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

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.

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

children under 12 years of age

do not use

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.
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.
Other Information (Other information)
  • each packet contains: potassium 6 mg
  • aspartame free, sodium free
  • store at room temperature. Protect from excessive heat and moisture.
Principal Display
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-866-467-2748

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 If (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
  • 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.
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.

If Pregnant Or Breast Feeding, (If pregnant or breast- feeding,)

ask a health care professional before use.

Active Ingredients (in Each Packet) (Active ingredients (in each packet))

Acetaminophen, 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (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
Additional Information Listed On Other Panels

Compare to the active ingredient in Theraflu Nighttime Severe Cold &Cough*

NDC 41226-541-06

NIGHTTIME

SEVERE COLD

& COUGH

Acetaminophen/Pain Reliever/ Fever Reducer

Diphenhydramine HCl /

Antihistamine/ Cough Suppressant

Phenylephrine HCl / Nasal Decongestant

Relieves

  • Cough
  • Nasal Congestion
  • Sore Throat Pain
  • Headache
  • Body ache
  • Fever
  • Runny nose
  • Sneezing

Honey Lemon

Infused with Chamomile & White Tea Flavors

6 Packets

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

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

Distributed by:

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Nighttime Severe Cold & Cough.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:40.762888 · Updated: 2026-03-14T23:09:34.496634