Label: DAYTIME COLD AND FLU- acetaminophine dextromethorphan hbr phenylphrine hcl capsule, liquid filled
- NDC Code(s): 0363-0853-07, 0363-0853-16, 0363-0853-24
- Packager: WALGREENS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 15, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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 every day 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
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 DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough get 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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DAYTIME COLD AND FLU
acetaminophine dextromethorphan hbr phenylphrine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0853 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 DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) POVIDONE (UNII: FZ989GH94E) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN (UNII: 6O92ICV9RU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GELATIN (UNII: 2G86QN327L) SHELLAC (UNII: 46N107B71O) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color orange Score no score Shape OVAL (Obong shaped) Size 21mm Flavor Imprint Code 70 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0853-16 2 in 1 CARTON 10/15/2021 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0363-0853-24 2 in 1 CARTON 10/15/2021 2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0363-0853-07 1 in 1 CARTON 07/03/2023 3 10 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 Drug M012 10/15/2021 Labeler - WALGREENS (008965063) Registrant - TIME CAP LABORATORIES INC. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(0363-0853)