Label: FAMILY DOLLAR NIGHTTIME 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
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Updated May 19, 2017
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- ACTIVE INGREDIENT
- temporarily relieves these symptoms due to a cold:
- minor aches and pains - headache - minor sore throat pain
- nasal and sinus congestion - cough due to minor throat and bronchial irritation
- runny nose - sneezing - itchy, watery eyes due to hay fever
- itchy nose and throat
- temporarily reduces fever.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets in 24 hours, which is the maximum daily amount - 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 redenning - blisters - rash. If a skin reaction occurs, stop use and seek medical help right away.
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:
- In a child under 4 years of age
- If you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription and nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on the skin
- If you are now taking a prescription monoamine oxidase (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 use if you have
- liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - 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.
- a sodium restricted diet.
- ASK DOCTOR/PHARMACIST
- INDICATIONS & USAGE
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.
Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet
- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- 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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
FAMILY DOLLAR NIGHTTIME 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:64525-0566 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MALTODEXTRIN (UNII: 7CVR7L4A2D) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) ACESULFAME (UNII: MA3UYZ6K1H) ASPARTAME (UNII: Z0H242BBR1) Product Characteristics Color yellow (Caramel Color) , yellow (D & C Yellow 10) Score Shape Size Flavor HONEY (Natural Honey and Lemon Flavor) , LEMON (Natural Honey and Lemon Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64525-0566-6 6 in 1 BOX; Type 0: Not a Combination Product 11/24/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/24/2015 Labeler - Quality Home Products (205554157)