Label: COLD TABS II- acetaminophen, guaifenesin and phenylephrine hcl tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 67060-106-02, 67060-106-68 - Packager: ADVANCED FIRST AID, INC.
- 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.
Drug Label Information
Updated October 25, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses: temporarily: • relieves nasal congestion associated with sinusitis • relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • relieves sinus congestion and pressure, helps decongest sinus openings and passages • restores free breathing • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive. temporarily relieves minor aches, pains, and fever associated with: • headache • common cold • toothache • backache • muscular aches • menstrual cramps
-
WARNINGS
Warnings:
Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: • you take more than 8 tablets in 24 hours • you take with other drugs containing acetaminophen (prescription or non-prescription) • you have 3 or more alcoholic drinks every day while using this product
Do not use: • with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. • more than the recommended dose • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor • when using this product do not exceed recommended dose • 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before
taking this product.
Stop use and ask a doctor if: • symptoms do not improve • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present • nervousness, dizziness or sleeplessness occur • symptoms do not improve within 7 days or are accompanied by fever cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.
Ask a doctor before use if you have: • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
COLD TABS II
acetaminophen, guaifenesin and phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67060-106 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color pink (ROSE PINK) Score no score Shape ROUND Size 12mm Flavor CHERRY Imprint Code FR8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67060-106-68 100 in 1 CARTON 04/10/2015 1 NDC:67060-106-02 2 in 1 PACKET; 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 04/10/2015 Labeler - ADVANCED FIRST AID, INC. (114477180) Registrant - ADVANCED FIRST AID, INC. (114477180) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 085752004 pack(67060-106) Establishment Name Address ID/FEI Business Operations ULTRA TAB LABORATORIES, INC. 151051757 manufacture(67060-106)