Label: NON DROWSY DAYTIME COLD AND FLU SOFTGEL- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 30142-768-48 - Packager: KROGER COMPANY
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 7, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- 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, lasts 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
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough get worse or last 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.
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Directions
- take only as directed - see Overdose warning
- do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use - Other information
- Inactive ingredients
- Questions or comments
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PRINCIPAL DISPLAY PANEL - 48 Softgel Blister Pack Carton
COMPARE TO the active ingredients of VICKS® DAYQUIL™
COLD & FLU RELIEF LIQUICAPS™ *See bottom panelNDC 30142-768-48
POWERFUL
NON-DROWSY
RELIEFKroger®
OUR PHARMACIST RECOMMENDED
Cold & Flu
DayTime
Multi-Symptom ReliefAcetaminophen
Dextromethorphan HBr
Phenylephrine HClactual
sizePain Reliever
Fever Reducer
Cough Suppressant
Nasal Decongestant48 SOFTGELS
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INGREDIENTS AND APPEARANCE
NON DROWSY DAYTIME COLD AND FLU SOFTGEL
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-768 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) Propylene Glycol (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score no score Shape OVAL Size 20mm Flavor Imprint Code 786 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-768-48 4 in 1 CARTON 05/01/2021 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 05/01/2021 Labeler - KROGER COMPANY (006999528)