Label: PREMIER VALUE DAY TIME SEVERE COLD AND COUGH- acetaminophen, dextromethorphan hbr, and phenylephrine hcl. granule, for solution
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated October 19, 2009
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- ACTIVE INGREDIENT
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
-more than 6 packets in 24 hours
-with other drugs containing acetaminophen
-3 or more alcoholic drinks every day while using this product
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.
Ask a doctor before us if you have
-liver disease -heart disease -high blood pressure
-thyroid disease -diabetes -trouble urinating due to an enlarged prostate gland
-cough that occurs with too much phlegm (mucus)
-cough that lasts or is chronic such as occurs with smoking, asthma or emphysema.
As a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
DO NOT USE
When using this product
-do not exceed recommended dosage
Stop use and ask a doctor if
-nervousness, dizziness, or sleeplessness occurs -fever gets worse or lasts more than 3 days
-redness or swelling is present
-new symptoms occur
-symptoms do not get better or worsen
-pain, cough or nasal congestion gets worse or lasts more than 7 days
-cough comes back or occurs with fever, 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
-do not use more than directed
-take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor
-adults and children 12 years of age and over; dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
-children under 12 years of age: consult a doctor
-if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
- INFORMATION FOR PATIENTS
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
PREMIER VALUE DAY TIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS
acetaminophen, dextromethorphan hbr, and phenylephrine hcl. granule, for solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64525-0547 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 650 mg Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextrose - UNII:IY9XDZ35W2) Dextromethorphan Hydrobromide 20 mg Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 10 mg Inactive Ingredients Ingredient Name Strength Acesulfame (UNII: MA3UYZ6K1H) Aspartame (UNII: Z0H242BBR1) citric acid monohydrate (UNII: 2968PHW8QP) Maltodextrin (UNII: 7CVR7L4A2D) Sodium Citrate (UNII: 1Q73Q2JULR) Sucrose (UNII: C151H8M554) Product Characteristics Color red (FD & C red No. 40) , blue (FD & C blue No.1) Score Shape Size Flavor BERRY (Berry infused with menthol & Green tea flavors) , MENTHOL (menthol) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64525-0547-6 6 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/31/2009 Labeler - Quality Home Products (205554157)