Label: ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCL capsule, liquid filled
- NDC Code(s): 41226-628-16
- Packager: Kroger Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 15, 2025
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
- temporarily relieves these common cold and flu symptoms:
nasal congestion
headache
cough
stuffy nose
minor aches and pains
sore throat
sinus congestion and pressure- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- DOSAGE & ADMINISTRATION
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 softgels in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
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.
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
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 fever, rash or headache that lasts. These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCL
acetaminophen, dextromethorphan hbr, guailfenesin,phenlyephrine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41226-628 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength SHELLAC (UNII: 46N107B71O) SORBITAN (UNII: 6O92ICV9RU) GELATIN (UNII: 2G86QN327L) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL SOLUTION (UNII: 8KW3E207O2) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POVIDONE (UNII: FZ989GH94E) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color orange Score no score Shape CAPSULE Size 10mm Flavor Imprint Code 78 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41226-628-16 16 in 1 BLISTER PACK; Type 0: Not a Combination Product 12/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 12/21/2020 Labeler - Kroger Company (006999528) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations marksans pharma ltd 925822975 manufacture(41226-628)
