Label: PREMIER VALUE NIGHT TIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS- acetaminophen, diphenhydramine hcl, 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
If you are a consumer or patient please visit this version.
- 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.
DO NOT USE
Do not use
- with any other drug containing acetaminophen (prescription and non prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
- with any other product containing diphenhydramine, even one used on the skin
-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 a MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before us if you have
- liver disease - heart disease - high blood pressure
- thyroid disease - diabetes - glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema, asthma, or chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema.
- ASK DOCTOR/PHARMACIST
- WHEN USING
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 NIGHT TIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS
acetaminophen, diphenhydramine hcl, and phenylephrine hcl. granule, for solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64525-0548 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 650 mg Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 25 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 yellow (Carmel Color) , yellow (D & C Yellow 10) Score Shape Size Flavor HONEY (Natural Honey & Lemon Flavor) , LEMON (Natural Honey & Lemon Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64525-0548-6 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)