Active Ingredients (In Each Packet) – Daytime Severe Cold Relief
Acetaminophen 500 mg
Dextromethorphan hydrobromide 20 mg
Kroger Kit
FDA Label NDC 41226-583
26 label sections · Submitted to the FDA by Kroger Company · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Kroger (NDC 41226-583). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each packet) – daytime severe cold relief, active ingredients (in each packet) - nighttime severe cold relief, purpose - daytime severe cold relief, purpose - nighttime severe cold relief, uses - daytime severe cold relief, uses - nighttime severe cold relief, warnings – daytime severe cold relief /nighttime severe cold relief, do not use - daytime severe cold relief, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Packet) - Nighttime Severe Cold Relief
Acetaminophen 650 mg
Diphenhydramine hydrochloride 25 mg
Purpose - Daytime Severe Cold Relief
Pain reliever/fever reducer
Cough Suppressant
Purpose - Nighttime Severe Cold Relief
Pain reliever/fever reducer
Antihistamine/Cough suppressant
Uses - Daytime Severe Cold Relief
▪ temporarily relieves these symptoms due to a cold:▪ minor aches and pains▪ minor sore throat pain▪ headache▪ cough due to minor throat and bronchial irritation▪ temporarily reduces fever
Uses - Nighttime Severe Cold Relief
▪ temporarily relieves these symptoms due to a cold:▪ minor aches and pains▪ minor sore throat pain▪ headache▪ 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 – Daytime Severe Cold Relief /Nighttime Severe Cold Relief
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▪ skin reddening▪ blisters▪ rash
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.
Do Not Use - Daytime Severe Cold Relief
▪ 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.▪ 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 an MAOI, ask a doctor or pharmacist before taking this product.
Do Not Use - Nighttime Severe Cold Relief
▪ 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 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 an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have - Daytime Severe Cold Relief
▪ liver disease▪ 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 Before Use If You Have - Nighttime Severe Cold Relief
▪ liver disease▪ glaucoma▪ trouble urinating due to an enlarged prostate gland▪ a breathing problem such as emphysema 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 - Daytime Severe Cold Relief
▪ taking the blood thinning drug warfarin
Ask A Doctor Or Pharmacist Before Use If You Are - Nighttime Severe Cold Relief
▪ taking sedatives or tranquilizers▪ taking the blood thinning drug warfarin
When Using This Product - Daytime Severe Cold Relief
do not exceed recommended dosage
When Using This Product - Nighttime Severe Cold Relief
▪ 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 – Daytime Severe Cold Relief /Nighttime Severe Cold And Cough
▪ fever gets worse or lasts more than 3 days▪ redness or swelling is present▪ new symptoms occur▪ pain, or cough gets worse or lasts more than 7 days▪ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away (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 – Daytime Severe Cold Relief
▪ do not use more than directed▪ take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor▪ 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
Age | Dose |
Adults and children 12 years of age and over | One packet |
Children under 12 years of age | Do not use |
Directions Nighttime Severe Cold Relief
▪ do not use more than directed▪ take every 4 hours while symptoms persist, Do not take more than 5 packets in 24 hours unless directed by a doctor▪ 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.
Age | Dose |
Adults and Children 12 years of age and over | One packet |
Children under 12 years of age | do not use |
Other Information - Daytime Severe Cold Relief
▪ each packet contains:potassium 5 mg▪ sodium free▪ store at room temperature. Protect product from heat and moisture.
Other Information - Nighttime Severe Cold Relief
▪ each packet contains: potassium 5 mg▪ sodium free▪ store at room temperature. Protect product from heat and moisture
Inactive Ingredients - Daytime Severe Cold Relief
anhydrous citric acid, caramel, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose
Inactive Ingredients - Nighttime Severe Cold Relief
Anhydrous citric acid, F D & C yellow No. 6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,
Questions Or Comments?
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Package/Label Principal Display Panel
COMBO PACK
MULTI-SYMPTOM COLD RELIEF
Compare to the active ingredients in Multi Symptom Theraflu® Severe Cold Relief Combo pack*
NDC 41226-583-12
Daytime SEVERE COLD RELIEF
Acetaminophen - Pain Reliever/ Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Hot liquid therapy that relieves
- Cough
- Head & Body ache
- Sore throat pain
- Fever
- Cough
- Head & Body ache
- Sore throat pain
- Runny nose
- Sneezing
- Fever
Honey Lemon Flavor
Nighttime SEVERE COLD RELIEF
Acetaminophen - Pain Reliever/ Fever Reducer
Diphenhydramine HCl – Antihistamine/Cough Suppressant
Hot liquid therapy that relieves
Honey lemon flavor
6 NIGHTTIME PACKETS
12 TOTAL PACKETS
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE, DO NOT DISCARD. |
DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 –HOUR PERIOD. |
DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF DAYTIME PRODUCT UNLESS DIRECTED BY DOCTOR. |
*This Products is not manufactured or distributed by Haleon, distributor of Multi-Symptom Theraflu® Severe Cold Relief Combo Pack.
Distributed By:
TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN |
Krogerdaytime And Nighttime Relief Value Pack 12 Packets (Image 01)
* Please review the disclaimer below.
