Sinus Relief Pressure and Pain
Kroger 44-628 Delisted
98de5cff-3ff5-49b0-bef9-5b9ebb86491e
HUMAN OTC DRUG LABEL
Aug 27, 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, Guaifenesin, Phenylephrine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (18)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal display panel
Kroger®
NDC 30142-828-09
FOR AGES 12+
Maximum Strength
Sinus Relief
PRESSURE & PAIN
**Acetaminophen /**Pain Reliever
Guaifenesin / Expectorant
Phenylephrine HCl /
Nasal Decongestant
RELIEVES:
****Sinus Pressure
& Congestion
Headache
Thins & Loosens Mucus
20
****CAPLETS
actual
size
Our Pharmacist Recommended
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
DISTRIBUTED BY
THE KROGER CO.
CINCINNATI, OHIO
45202
QUALITY GUARANTEE
800-632-6900
www.kroger.com
50844 REV0419B62809
Kroger 44-628
INDICATIONS & USAGE SECTION
Uses
-
temporarily relieves:
-
nasal congestion
-
headache
-
sinus congestion and pressure
-
minor aches and pains
-
-
temporarily promotes nasal and/or sinus drainage
-
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each caplet)
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever
Expectorant
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.
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
-
heart disease
-
diabetes
-
thyroid disease
-
difficulty in urination due to enlargement of the prostate gland
-
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
-
liver disease
-
high blood pressure
-
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
-
fever gets worse or lasts more than 3 days
-
pain, nasal congestion, or cough gets worse or lasts more than 7 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
-
do not take more than 12 caplets in any 24-hour period
-
adults and children 12 years and over: take 2 caplets every 4 hours
-
children under 12 years: do not use
STORAGE AND HANDLING SECTION
Other information
*TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
-
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
-
see end flap for expiration date and lot number
INACTIVE INGREDIENT SECTION
Inactive ingredients
corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
1-800-632-6900