Cold Multi-Symptom
Kroger 44-470C
f4429475-47f9-451a-bfcc-24b5ef333923
HUMAN OTC DRUG LABEL
May 23, 2025
Kroger Company
DUNS: 006999528
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (16)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel
COMPARE TO the active ingredients of TYLENOL® COLD MAX*See bottom panel
NDC 30142-470-08
Kroger®
DayTime
Cold Multi-Symptom
Acetaminophen
****Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
NON-DROWSY
****Headache
Fever, Sore Throat
Nasal Congestion
Cough
OUR PHARMACIST RECOMMENDED
actual size
24CAPLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IF OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*Tylenol® Cold Max is a registered trademark of Johnson & Johnson Corporation. New Brunswick, New Jersey 08933, Johnson & Johnson Corporation is not affiliated with The Kroger Co. or this product.
50844 ORG071847008
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
ForMore Product Information, Scan UPC
****Using YourKroger Appor Call 800-632-6900
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PARENTS:
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Kroger 44-470C
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- nasal congestion
- headache
- cough
- sinus congestion and pressure
- sore throat
- helps clear nasal passages
- promotes nasal and sinus drainage
- temporarily reduces fever
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
WARNINGS SECTION
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:
- blisters
- rash
- skin reddening
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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
-
liver disease
-
diabetes
-
heart disease
-
thyroid disease
-
high blood pressure
-
difficulty in urination due to enlargement of the prostate gland
-
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
-
cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
When using this product
do not exceed recommended dosage.
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
*do not take more than directed
- adults and children 12 years and over
- take 2 caplets every 4 hours
- swallow whole - do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
- children under 12 years: ask a doctor
STORAGE AND HANDLING SECTION
Other information
*TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
INACTIVE INGREDIENT SECTION
Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
1-800-632-6900