Label: DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule
- NDC Code(s): 58602-768-15
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 1, 2024
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- Official Label (Printer Friendly)
- Active ingredients (in each capsule)
- Purpose
- Uses
-
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses 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
Sore throatwarning:If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
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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
- Ask a doctor or pharmacist before use if you are
- When using this product, do not use more than directed.
-
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- symptoms get worse or last more than 5 days (children) or 7 days (adults)
- 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,
- Keep out of reach of children.
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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 capsules with water every 4 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
- when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
- Other information
- Inactive ingredients
- QUESTIONS
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - (16 Capsules Bottle)
AUROHEALTH
NDC 58602-768-15
Compare to the active ingredients
in VICKS ®DayQuil ®Cold & Flu
Multi-Symptom Relief LiquiCaps ®*
Multi-Symptom Relief
Non-Drowsy
Daytime Relief
Cold & Flu
Acetaminophen, Dextromethorphan HBr and
Phenylephrine HCl Capsules
325 mg/10 mg/5 mg- Aches, Fever & Sore Throat
- Nasal Congestion
- Cough
16 Capsules
-
INGREDIENTS AND APPEARANCE
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-768 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 GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color orange (Orange to Reddish Brown) Score no score Shape OVAL Size 20mm Flavor Imprint Code Q01 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-768-15 16 in 1 BOTTLE; Type 0: Not a Combination Product 12/31/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 12/31/2019 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650844777 manufacture(58602-768)