![DAYTIME COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [AMERICAN SALES COMPANY]](https://medic.hrt.org//dailymed/images/b2d86c05-ec1a-4676-94e4-82f8be38b281/daytime-cold-and-flu-relief-softgels-1.jpg)
| NDC | 41520-473-16, 41520-473-24 |
| Set ID | b2d86c05-ec1a-4676-94e4-82f8be38b281 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Care One (American Sales Company) |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active Ingredients (in each softgel)
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product.
Sore throat warning: 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.
Do not use
- with any other drug containing acetaminophen (prescription or non prescription). 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 an 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
- 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.
Keep out of reach of children.
Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.
-
Directions
- take only as directed- see overdose warning
- do not exceed 4 doses per 24 hours
adults and children 12 years and over swallow 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use - when using other daytime or nitetime products, carefully read each label to insure correct dosing
- Other information
- Inactive Ingredients
- Questions or comments?
-
Product Labeling
Compare to active ingredients in Vicks® Dayquil® **
**This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil®
Non- drowsy
daytime liquid caps multi symptom cold/ flu relief
acetaminophen, dextromethorphan hydrobromide, phenylephrine HCl
pain reliever, fever reducer, cough suppressant, nasal congestantRelieves major cold and flu symptoms
Aches & fever, sore throat, coughing, congestion
Distributed by
American sales company
4201 walden avenue
Lancaster NY 14086
1-877-846-9949
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
Daytime liquid caps cold and flu relief
-
INGREDIENTS AND APPEARANCE
DAYTIME COLD AND FLU RELIEF
acetaminohpen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-473 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 BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 19mm Flavor Imprint Code P19;95A;36A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-473-24 2 in 1 CARTON 11/15/2012 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:41520-473-16 2 in 1 CARTON 11/15/2012 2 8 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 11/15/2012 Labeler - Care One (American Sales Company) (809183973)